Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI)



Status:Completed
Conditions:Angina, Angina, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/27/2013
Start Date:October 2011
End Date:March 2014

Use our guide to learn which trials are right for you!

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Ranolazine on Major Adverse Cardiovascular Events in Subjects With a History of Chronic Angina Who Undergo Percutaneous Coronary Intervention With Incomplete Revascularization


This study will evaluate the efficacy of ranolazine as compared with placebo when used as
part of standard medical therapy in chronic angina subjects with incomplete
revascularization post-PCI on the composite of ischemia-driven revascularization or
ischemia-driven hospitalization without revascularization.


Inclusion Criteria

1. Written informed consent

2. Males and females aged 18 years and older

3. History of chronic angina defined as at least 2 episodes of anginal pain or
discomfort in the chest, jaw, shoulder, back, neck, or arm that is precipitated by
exertion or emotional stress, and relieved by rest or sublingual nitroglycerin, which
occurred on at least 2 separate days and at least 14 days prior to PCI (in the case
of staged PCI procedures, at least 14 days prior to the first PCI in the series).
Subjects may or may not have additional angina episodes within the 14 days prior to
their first PCI in the series, as well as anytime prior to Randomization.

4. PCI for any indication (ACS or non-ACS). For the purposes of stratification at
randomization, ACS will be defined as hospitalization for anginal pain or discomfort
within the previous 24 hours to their hospitalization with any one (or more) of the
following criteria:

i. Elevated troponin or creatinine kinase-MB (CK-MB) consistent with MI, as
reported by local laboratory and measured prior to index PCI ii.
Electrocardiographic changes (including transient changes) comprising new or
presumably new ST segment depression ≥ 0.1 mV (≥ 1 mm), or ST segment elevation ≥ 0.1
mV (≥ 1 mm) in at least 2 contiguous leads, or new or presumably new Left Bundle
Branch Block

5. Randomization within 14 days post-PCI. In the case of staged PCI procedures,
randomization has to occur within 14 days of the last PCI in the series. Subjects may
be randomized starting on the day of PCI and anytime during the following 14 days.
PCI is defined as an attempt to cross the lesion with a wire with the intention of
performing revascularization.

6. Post-PCI (post the last PCI for staged procedures) evidence of incomplete
revascularization defined as the presence of one or more visually estimated ≥ 50%
stenoses in one or more coronary arteries with reference vessel diameter of at least
2.0 mm, whether in the target vessel or in a non-target vessel regardless of the
presence or absence of coronary collaterals. In the case of a subject post-CABG,
incomplete revascularization is defined as the presence of one or more visually
estimated ≥ 50% stenoses in an unbypassed epicardial vessel with a reference diameter
of ≥ 2.0 mm, or one or more visually estimated ≥ 50% stenoses in a bypass graft
supplying an otherwise unrevascularized myocardial territory.

7. Clinically stable post-PCI. Subjects randomized in-hospital on day of planned
discharge or in clinic are considered stable. Subjects randomized in-hospital prior
to day of planned discharge must meet all of the following criteria:

i. CK-MB < 3 times the upper limit of normal (ULN) at least 3 hours post-PCI, or if ≥
3 times the ULN with evidence of decreasing CK-MB (decreased by at least 20% from the
prior measurement) as reported by local laboratory. If CK-MB is not available, a
subject must have evidence of normal or decreasing troponin levels (by at least 20%
from the prior measurement) at least 3 hours post-PCI, as reported by local
laboratory.

ii. Systolic blood pressure ≥ 90 mm Hg and not receiving pressors or inotropes iii.
No current requirement for an intra-aortic balloon pump (IABP) or any left
ventricular assist device iv. No current requirement for intravenous (IV)
nitroglycerin

8. Ability and willingness to comply with all study procedures during the course of the
study

9. Females of childbearing potential must have a negative pregnancy test at Screening
(unless surgically sterile or post menopausal) and must agree to use highly effective
contraception methods from Screening throughout the duration of study treatment and
for 14 days following the last dose of study drug.

Exclusion Criteria

1. Any future planned revascularization (including staged procedures) or possible
planned revascularization (ie, planned stress test to assess the imminent need for
additional revascularization). Future planned stress tests for purposes of monitoring
are permitted but strongly discouraged. Subjects may be enrolled after the last PCI
in the staged series or once a decision is made not to perform a follow up PCI, as
long as Randomization occurs within 14 days from the last PCI. If a subject has had a
stress test post-PCI and prior to Randomization and no further intervention is
planned, the subject may be enrolled within 14 days from the last PCI.

2. Unrevascularized left main coronary artery stenosis ≥ 50%. Subjects with a history of
CABG to the left coronary system will be considered to have a revascularized left
main if at least one graft is patent.

3. Major complication during or after the index PCI (in the case of staged PCI, the last
in the series) including:

i. Major bleeding (TIMI Bleeding classification or any bleeding requiring blood
transfusion of ≥ 2 units of red blood cells) ii. Coronary perforation requiring
treatment iii. Procedural complication requiring surgery (including CABG or
peripheral vascular surgery)

4. Stroke within 90 days prior to Randomization, or any history of stroke with permanent
major neurologic disability (eg, aphasia or significant motor dysfunction)

5. Cardiogenic shock within 90 days prior to Randomization (transient decreases in blood
pressure without clinical sequelae are not considered to be cardiogenic shock)

6. New York Heart Association (NYHA) Class III or IV heart failure

7. Severe renal insufficiency as assessed by an estimated GFR < 30 mL/min/1.73m2 using
the 4 variable modification of diet in renal disease (MDRD) equation per local
laboratory (based on the last available measurement prior to Randomization, collected
within 1 month prior to the index PCI [in the case of staged PCI, the last in the
series])

8. Liver cirrhosis

9. Use of Class Ia, Ic, or Class III antiarrhythmics, except for amiodarone

10. Current treatment with strong inhibitors of CYP3A

11. Current treatment with CYP3A4 inducers or P-gp inducers

12. Subjects taking > 20 mg simvastatin daily or > 40 mg lovastatin daily who cannot
reduce the dose to 20 mg once daily for simvastatin or 40 mg once daily for
lovastatin, or who cannot switch to another statin

13. Subjects taking greater than a total of 1000 mg daily of metformin who cannot reduce
the dose to a maximum total of 1000 mg daily (additional anti-diabetic medications
may be added as clinically indicated to allow subjects to decrease their metformin
dose and maintain glycemic control)

14. Previous treatment with ranolazine for > 7 consecutive days within 30 days prior to
Randomization, or known hypersensitivity or intolerance to ranolazine or to any of
the excipients

15. Participation in another investigational drug or investigational device study within
30 days prior to Randomization (participation in registries is allowed)

16. Women who are pregnant or breast feeding

17. Non-CAD comorbid conditions (eg, advanced malignancy, severe aortic stenosis) which
are likely to result in death within 2 years of Randomization

18. Any condition that in the opinion of the investigator would preclude compliance with
the study protocol
We found this trial at
110
sites
?
mi
from
Boise, ID
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
1600 S. Andrews Ave.
Fort Lauderdale, Florida 33316
954-355-4400
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
11701 San Jose Blvd # 32
Jacksonville, Florida 32223
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Mayo Clinic - Jacksonville Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
920 Madison Ave
Memphis, Tennessee 38163
?
mi
from
Memphis, TN
Click here to add this to my saved trials
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
?
mi
from
Providence, RI
Click here to add this to my saved trials
9500 Gilman Dr
San Diego, California 92093
(858) 534-2230
University of California at San Diego UC San Diego is dedicated to the advancement of...
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Albany, New York 12212
?
mi
from
Albany, NY
Click here to add this to my saved trials
Anderson, South Carolina 29621
?
mi
from
Anderson, SC
Click here to add this to my saved trials
Asheville, North Carolina 28802
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Baltimore, Maryland
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21215
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bangor, Maine 04401
?
mi
from
Bangor, ME
Click here to add this to my saved trials
Beaver, Pennsylvania 15009
?
mi
from
Beaver, PA
Click here to add this to my saved trials
Birmingham, Alabama 35211
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts 02135
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boynton Beach, Florida 33437
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Buffalo, New York 14215
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
?
mi
from
Burlington, VT
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Columbus, Ohio 43214
?
mi
from
Columbus, OH
Click here to add this to my saved trials
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Cortlandt Manor, New York 10567
?
mi
from
Cortlandt Manor, NY
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
?
mi
from
Danville, PA
Click here to add this to my saved trials
Daytona Beach, Florida 32117
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
Dearborn, Michigan 48123
?
mi
from
Dearborn, MI
Click here to add this to my saved trials
Des Moines, Iowa 50314
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Doylestown, Pennsylvania 18901
?
mi
from
Doylestown, PA
Click here to add this to my saved trials
Duluth, Minnesota 55805
?
mi
from
Duluth, MN
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
Erie, Pennsylvania 16502
?
mi
from
Erie, PA
Click here to add this to my saved trials
Harrisburg, Pennsylvania 17101
?
mi
from
Harrisburg, PA
Click here to add this to my saved trials
Hialeah, Florida 33010
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hialeah, Florida 33010
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
High Point, North Carolina 27262
?
mi
from
High Point, NC
Click here to add this to my saved trials
Humble, Texas 77338
?
mi
from
Humble, TX
Click here to add this to my saved trials
Huntsville, Alabama 35801
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Hyannis, Massachusetts 02601
?
mi
from
Hyannis, MA
Click here to add this to my saved trials
Indianapolis, Indiana 46237
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46250
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jackson, Tennessee 38301
?
mi
from
Jackson, TN
Click here to add this to my saved trials
Jacksonville, Florida 32207
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jacksonville, Florida 32204
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jerseyville, Illinois 62052
?
mi
from
Jerseyville, IL
Click here to add this to my saved trials
Joplin, Missouri 64804
?
mi
from
Joplin, MO
Click here to add this to my saved trials
Kettering, Ohio 45249
?
mi
from
Kettering, OH
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Layton, Utah 84041
?
mi
from
Layton, UT
Click here to add this to my saved trials
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Lexington, Kentucky 40504
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Littleton, Colorado 80120
?
mi
from
Littleton, CO
Click here to add this to my saved trials
Liverpool, New York 13088
?
mi
from
Liverpool, NY
Click here to add this to my saved trials
Miami Beach, Florida 33140
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
Minden, Louisiana 71055
?
mi
from
Minden, LA
Click here to add this to my saved trials
Minneapolis, Minnesota 55407
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Mission, Texas 78572
?
mi
from
Mission, TX
Click here to add this to my saved trials
Moreno Valley, California 92553
?
mi
from
Moreno Valley, CA
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Newark, NJ
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oak Ridge, Tennessee 37830
?
mi
from
Oak Ridge, TN
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73135
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32803
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Panama City, FL
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15240
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Poughkeepsie, New York 12601
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
Raleigh, North Carolina 27610
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
3601 W 13 Mile Rd
Royal Oak, Michigan 48073
(248) 898-5000
William Beaumont Hospital-Royal Oak The largest Beaumont Hospital is located at 3601 W Thirteen Mile...
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
Saint Cloud, Minnesota 56303
?
mi
from
Saint Cloud, MN
Click here to add this to my saved trials
Saint Louis, Missouri 63128
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92161
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94121
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Scottsdale, Arizona 85259
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Springfield, Missouri 65804
?
mi
from
Springfield, MO
Click here to add this to my saved trials
Stamford, Connecticut 06905
?
mi
from
Stamford, CT
Click here to add this to my saved trials
101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Tallahassee, Florida 32308
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Teaneck, New Jersey 07666
?
mi
from
Teaneck, NJ
Click here to add this to my saved trials
Tucson, Arizona 85724
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
Utica, New York 13501
?
mi
from
Utica, NY
Click here to add this to my saved trials