Overview

REsistance to Aspirin and Clopidogrel in acuTe Myocardial Infarction

Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare 3 point-of-care methods for monitoring antiplatelet therapy to golden standard (Light transmittance aggregometry-LTA) in high risk population of acute myocardial infarction patients. If two methods (PFA-100, VerifyNOW,Multiplate or LTA) will indicate insufficient antiplatelet blockade/high residual reactivity for aspirin, clopidogrel or both, the dose of aspirin will be increased to 200mg qd and the dose of clopidogrel will be increased to 2x75mg qd.In addition genotyping of CYP2C19 (6 alleles) will be performed.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital Ostrava
Treatments:
Aspirin
Clopidogrel
Ticlopidine
Criteria
Inclusion Criteria:

- acute myocardial infarction (verified by troponin I elevation and ST-segment deviation
≥0.1mV in ≥2 contiguous ECG leads persisting for at least 20 minutes and
angiographical proof of coronary stenosis )

- preceding antiplatelet medication with aspirin100mg qd/5 and more days before PCI

- pre-treatment with 600mg Clopidogrel loading dose

- preferably patients with drug eluting stent implantation

- signed informed consent

Exclusion Criteria:

- stable/unstable angina pectoris

- active malignancy

- contraindication to antiplatelet therapy

- increased risk of bleeding (trauma, surgery or non-ischemic stroke in last month)

- effective anticoagulation therapy:LMWH, Pradaxa, Xarelto, Warfarin

- known thrombophile disorder

- SIRS

- renal insufficiency (eGFR under 15ml/min)

- severe anemia (<80 g/l)

- polyglobulia (>160 g/l)

- pregnancy

- Hematocrit <0.25 > 0.55