Overview

Aspirin Impact on Platelet Reactivity in Acute Coronary Syndrome Patients on Novel P2Y12 Inhibitors Therapy

Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
0
Participant gender:
All
Summary
Thus far, no study has evaluated the impact on aspirin in addition to the newer and more potent P2Y12 inhibitors, among ACS patients and current guidelines recommend dual anti-platelet therapy consisting of aspirin and a novel P2Y12 inhibitor in this population. Objective The investigators goal is to examine the effect of aspirin in addition to new anti-platelet agent (ticagrelor\prasugrel) on platelet reactivity in comparison with placebo, among ACS patients treated percutaneously. Design The proposed study is a randomized-controlled, double blind trial, conducted among ACS patients treated percutaneously. Eligible patients will recruited during hospitalization due to ACS after percutaneous coronary intervention (PCI), and randomization by envelopes on 1:1 basis will take place a month after the index event, at a follow-up visit at the cardiac clinic. Platelet function and Endothelial function tests will be taken a month after the index event, and at a 2 weeks periods following aspirin/placebo therapy, cross-over and return to open-label aspirin. End-points platelet function tests will be compared between aspirin and placebo therapy and before and after the cross-over.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sheba Medical Center
Treatments:
Aspirin
Criteria
Inclusion Criteria:

- Age>18 years

- ACS defined according to the 3rd universal definition of MI

- PCI therapy

Exclusion Criteria:

- Indication for anticoagulant therapy

- ACS on new P2Y12 inhibitors treatment

- Contraindication to P2Y12 therapy

- Renal failure defined as creatinine ≥1.5 mg/dL

- Non-compliance

- Life-threatening extra-cardiac disease or malignancy with a life expectancy below 1
year

- Inability to sign an informed consent

- Participation in another trial during the previous 6 months