Aspirin Resistance and Percutaneous Coronary Intervention (PCI)



Status:Completed
Conditions:Angina, Angina
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/16/2018
Start Date:April 2007
End Date:June 2009

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A Randomized, Pilot, Single-center Study, Investigator-Initiated Study to Look at an Aggressive Therapeutic Approach in Aspirin Resistant Patients Comparing to Standard for Patient Undergoing Percutaneous Coronary Intervention

The objective of this study is to evaluate if aggressive antiplatelet therapy would reduce
ischemic events in aspirin (ASA) resistant patients after percutaneous coronary intervention
(PCI).

This is the first US based randomized double blinded prospective study using triple
antiplatelet therapy and double dose plavix maintenance dose in aspirin resistant patients
undergoing elective PCI through femoral access. The primary outcome of this study is an
elevation of cardiac enzymes within 24 hours after the PCI with a secondary outcome of a
composite of major adverse cardiac events of death, MI, stent thrombosis and urgent
revascularization and bleeding up to 30 days.

Inclusion Criteria:

- Age older than 18 years

- Scheduled for elective or ad-hos PCI

- Aspirin use daily for greater or equal to one week

- Aspirin resistant (ARU greater than or equal to 550 on Verify Now-ASA

Exclusion Criteria:

- Pre-procedural elevation of cardiac biomarkers (CK-MB greater or equal to 10.4ng/dl or
Tnl greater or equal to 0.4ng/dl

- administration of any GP IIb/IIIa inhibitor, anticoagulation or lytic therapy in the
previous 30 days

- Ongoing bleeding or bleeding diathesis, contraindications for anticoagulation or
increased bleeding risk or history of bleeding in the last eight weeks

- Previous stroke or transient ischemic attack or any intracranial pathology in the last
six months, major surgery or trauma within the previous six weeks

- Platelet count less than hundred thousand per cubic millimeter or hematocrit <33% or
hemoglobin <11 g per deciliter

- Subjects who received full dose low molecular weight heparin within six hours prior to
randomization

- Allergy or intolerance to any of the study drugs or the presence of any serious
comorbidity with life expectancy of ≤1year

- Scheduled for saphenous vein graft intervention, chronic total occlusions or with
impaired renal function (eGFR<60ml/min) or patients who were taking anticoagulants or
antiplatelet agents other than aspirin and clopidogrel or nonsteroidal
anti-inflammatory drugs within two weeks before the PCI procedure
We found this trial at
1
site
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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mi
from
New York, NY
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