The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/25/2017
Start Date:December 2009
End Date:April 2014

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A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).

This study will test whether darapladib can safely lower the chances of having a
cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g.
medical procedures performed to restore the normal blood flow in patients with
atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome
(also called ACS).

Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo
administered in addition to standard therapy. Following the baseline visit, subjects will be
expected to return for clinic visits at 1 month, 3 months, 6 months and every 6 months until
the end of the study.

Inclusion Criteria:

- Signed written informed consent.

- Men or women at least 18 years old (in Taiwan, at least 20 years old). Women must be
post-menopausal or using a highly effective method for avoidance of pregnancy.

- Hospitalization for acute coronary syndrome (ACS) within 30 days prior to study
entry.

- Clinically stable for 24 hours prior to study entry.

- A planned percutaneous coronary intervention (PCI) should be performed prior to study
entry, whenever possible.

- At least one of the following:

- At least 60 years old.

- Myocardial infarction prior to the qualifying ACS event.

- Diabetes mellitus requiring treatment with medication.

- Diagnosed mild or moderate reduction in kidney function.

- Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months
prior to study entry) OR peripheral artery disease.

Exclusion Criteria:

- ACS symptoms or lab results not believed to be caused by a narrowing or blocked
coronary artery.

- No major coronary artery with a blockage of more than 50% (unless all stenoses are
successfully treated by PCI).

- Planned coronary artery bypass graft (CABG) surgery, or CABG surgery performed after
the qualifying ACS event and prior to study entry.

- Certain types of liver disease.

- Severe reduction in kidney function OR removal of a kidney OR kidney transplant.

- Severe heart failure.

- Blood pressure higher than normal despite lifestyle changes and treatment with
medications.

- Any life-threatening disease with a life expectancy of less than 2 years (other than
heart disease) that may prevent the subject from completing the study.

- Severe asthma that is poorly controlled with medication.

- Pregnancy (Note: A pregnancy test will be performed on all non-sterile women prior to
study entry).

- Previous severe allergic reaction to food, medications, drink, insect stings, etc.

- Drug or alcohol abuse within the past 6 months. Mental/psychological impairment that
may prevent the subject from complying with study procedures or understanding the
goal and potential risks of participating in the study.

- Certain medications that may interfere with the study medication (these will be
identified by the study doctor).

- If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must
have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less
than or equal to 20.0 nmol/min/mL are excluded.

- Previously took darapladib (SB-480848).

- Participation in a study of an investigational medication within the past 30 days.

- Current participation in a study of an investigational device.

- Any other reason the investigator deems the subject should not participate in the
study.
We found this trial at
259
sites
Raleigh, North Carolina 27614
1066
mi
from
Raleigh, NC
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Albany, New York 12206
1308
mi
from
Albany, NY
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Albuquerque, New Mexico 87109
517
mi
from
Albuquerque, NM
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Alexandria, Louisiana 71301
539
mi
from
Alexandria, LA
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Allentown, Pennsylvania 18102
1209
mi
from
Allentown, PA
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Amarillo, Texas 79106
286
mi
from
Amarillo, TX
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Anchorage, Alaska 99508
2732
mi
from
Anchorage, AK
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Ann Arbor, Michigan 48109
810
mi
from
Ann Arbor, MI
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Asheville, North Carolina 28803
859
mi
from
Asheville, NC
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Atlanta, Georgia 30341
801
mi
from
Atlanta, GA
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Atlantis, Florida 33462
1287
mi
from
Atlantis, FL
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Augusta, Georgia 30909
931
mi
from
Augusta, GA
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Aurora, Illinois 60504
579
mi
from
Aurora, IL
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Austin, Texas 78705
515
mi
from
Austin, TX
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Aventura, Florida 33180
1315
mi
from
Aventura, FL
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Avon, Indiana 46123
630
mi
from
Avon, IN
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Ayer, Massachusetts 01432
1418
mi
from
Ayer, MA
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Bakersfield, California 93309
1187
mi
from
Bakersfield, CA
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Baltimore, Maryland 21201
1148
mi
from
Baltimore, MD
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Bangor, Maine 04401
1575
mi
from
Bangor, ME
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Bannockburn, Illinois 60015
609
mi
from
Bannockburn, IL
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Beaver, Pennsylvania 15009
957
mi
from
Beaver, PA
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Bel Air, Maryland 21014
1162
mi
from
Bel Air, MD
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Bellevue, Washington 98004
1405
mi
from
Bellevue, WA
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Bellingham, Washington 98225
1445
mi
from
Bellingham, WA
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Beloit, Wisconsin 53511
568
mi
from
Beloit, WI
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Bethlehem, Pennsylvania 18105
1209
mi
from
Bethlehem, PA
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Beverly Hills, California 90211
1175
mi
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Beverly Hills, CA
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Birmingham, Alabama 35249
676
mi
from
Birmingham, AL
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Boise, Idaho 83712
1039
mi
from
Boise, ID
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Boston, Massachusetts 02115
1444
mi
from
Boston, MA
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Brandon, Florida 33511
1126
mi
from
Brandon, FL
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Bridgeport, Connecticut 06606
1329
mi
from
Bridgeport, CT
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Bronx, New York 10461
1295
mi
from
Bronx, NY
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Brooklyn, New York 11215
1288
mi
from
Brooklyn, NY
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Browns Mills, New Jersey 08015
1255
mi
from
Browns Mills, NJ
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Buffalo, New York 14263
1057
mi
from
Buffalo, NY
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Burien, Washington 98166
1407
mi
from
Burien, WA
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Burlington, North Carolina 27215
1020
mi
from
Burlington, NC
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Camp Hill, Pennsylvania 17011
1132
mi
from
Camp Hill, PA
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Canton, Ohio 44708
899
mi
from
Canton, OH
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Capital Federal, Buenos Aires
5602
mi
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Capital Federal,
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Chambersburg, Pennsylvania 17201
1092
mi
from
Chambersburg, PA
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Charleston, South Carolina 29425
1063
mi
from
Charleston, SC
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Charlotte, North Carolina 28203
957
mi
from
Charlotte, NC
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Chattanooga, Tennessee 37421
728
mi
from
Chattanooga, TN
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Chicago, Illinois 60611
611
mi
from
Chicago, IL
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Cincinnati, Ohio 45229
727
mi
from
Cincinnati, OH
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Clearwater, Florida 33759
1105
mi
from
Clearwater, FL
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Cleveland, Ohio 44195
898
mi
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Cleveland, OH
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Colorado Springs, Colorado 80910
383
mi
from
Colorado Springs, CO
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Columbia, Maryland 21044
1134
mi
from
Columbia, MD
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Columbia, Missouri 65201
308
mi
from
Columbia, MO
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Columbia, Montana 65201
308
mi
from
Columbia, MT
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Columbia, South Carolina 29203
969
mi
from
Columbia, SC
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Columbia, Tennessee 38401
615
mi
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Columbia, TN
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Concord, North Carolina 28025
968
mi
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Concord, NC
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Corpus Christi/Texas, Texas 78404
690
mi
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Corpus Christi/Texas, TX
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Cortlandt Manor, New York 10567
1295
mi
from
Cortlandt Manor, NY
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Cottonwood, Arizona 86326
816
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Cottonwood, AZ
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Crestview Hill, Kentucky 41017
723
mi
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Crestview Hill, KY
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Cumming, Georgia 30041
802
mi
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Cumming, GA
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Dallas, Texas 75230
340
mi
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Dallas, TX
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Dayton, Ohio 45420
749
mi
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Dayton, OH
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Daytona Beach, Florida 32117
1127
mi
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Daytona Beach, FL
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Dearborn, Michigan 48126
835
mi
from
Dearborn, MI
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Detroit, Michigan 48202
841
mi
from
Detroit, MI
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Doylestown, Pennsylvania 18901
1227
mi
from
Doylestown, PA
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Duluth, Minnesota 55805
690
mi
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Duluth, MN
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Elizabeth, New Jersey 07201
1276
mi
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Elizabeth, NJ
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Elmer, New Jersey 08318
1225
mi
from
Elmer, NJ
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Elyria, Ohio 44035
872
mi
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Elyria, OH
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Erie, Pennsylvania 16507
984
mi
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Erie, PA
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Everett, Washington 98201
1413
mi
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Everett, WA
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Fairfield, Ohio 45014
724
mi
from
Fairfield, OH
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Fairview Park, Ohio 44126
724
mi
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Fairview Park, OH
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Fall River, Massachusetts 02720
1439
mi
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Fall River, MA
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Fleming Island, Florida 32003
1061
mi
from
Fleming Island, FL
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Flint, Michigan 48504
824
mi
from
Flint, MI
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Fort Lauderdale, Florida 33308
1306
mi
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Fort Lauderdale, FL
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Fort Smith, Arkansas 72903
253
mi
from
Fort Smith, AR
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Fort Wayne, Indiana 46825
716
mi
from
Fort Wayne, IN
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Fort Worth, Texas 76104
348
mi
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Fort Worth, TX
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Fresno, California 93720
1205
mi
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Fresno, CA
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Gainesville, Florida 32610
1049
mi
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Gainesville, FL
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Galveston, Texas 77555
608
mi
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Galveston, TX
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Gastonia, North Carolina 28054
940
mi
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Gastonia, NC
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Glendale, Arizona 85304
854
mi
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Glendale, AZ
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Glendale, California 91204
1167
mi
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Glendale, CA
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Golden, Colorado 80401
421
mi
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Golden, CO
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Grand Forks, North Dakota 58201
704
mi
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Grand Forks, ND
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Grand Island, Nebraska 68803
220
mi
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Grand Island, NE
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Great Falls, Montana 59405
957
mi
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Great Falls, MT
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Greeley, Colorado 80631
412
mi
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Greeley, CO
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Green Bay, Wisconsin 54301
689
mi
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Green Bay, WI
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Greensboro, North Carolina 27403
999
mi
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Greensboro, NC
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Greenville, South Carolina 29615
883
mi
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Greenville, SC
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Guilford, Connecticut 06437
1357
mi
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Guilford, CT
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Gulf Breeze, Florida 32561
794
mi
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Gulf Breeze, FL
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Haddon Heights, New Jersey 08035
1230
mi
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Haddon Heights, NJ
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Hammond, Indiana 46320
608
mi
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Hammond, IN
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