Phase 2
N=36
Aspirin Resistance and Percutaneous Coronary Intervention (PCI)
Stable Angina
Bottom Line
View on ClinicalTrials.gov: NCT01103440 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Number of Participants With Elevation of Cardiac Enzyme — 4; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intravenous Glycoprotein inhibitor + ASA, Clopidogrel (Drug); Antiplatelet Therapy (ASA, Clopidogrel) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Elevation of Cardiac Enzyme |
4; 2 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac Event (MACE) |
5; 1 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01103440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.