Phase 2
Completed N=36
Aspirin Resistance and Percutaneous Coronary Intervention (PCI)
Source: ClinicalTrials.gov NCT01103440 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Number of Participants With Elevation of Cardiac Enzyme — 4; 2 Participants
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).
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 | — |
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. Informational only — not medical advice.