On-treatment PLAtelet Reactivity-guided Therapy Modification FOR ST-segment Elevation Myocardial Infarction

• Status: Terminated
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Adequate platelet inhibition with dual antiplatelet therapy is a key therapeutic goal after primary percutaneous coronary intervention (PPCI), aimed at protecting against stent thrombosis and increased mortality. Recent aggregometric assays have shown that up to one third of acute coronary syndrome patients treated with clopidogrel have incomplete inhibition of adenosine diphosphate(ADP)-induced platelet aggregation while the number of patients treated with aspirin who have incomplete inhibition of thromboxane A2-induced platelet aggregation (ASPI)is much lower. High on-treatment platelet reactivity (HTPR) has been associated with an increased rate of ischemic events after PCI. However, recent large trials did not show a clinical benefit of TPR-guided therapy modification in acute coronary syndrome patients treated by PCI.

On-treatment PLAtelet reactivity-guided Therapy modification FOR ST-segment elevation Myocardial infarction (PLATFORM) is an investigator-initiated, prospective, randomized, parallel-group, controlled clinical trial designed to test the hypothesis that antiplatelet therapy modification is superior to standard antiplatelet regimen among intermediate to high-risk STEMI patients undergoing PPCI. The safety hypothesis is that compared with control arm, interventional study arm will have similar rates of non-coronary artery bypass graft surgery-related bleeding. Approximately 632 ST-elevation myocardial infarction (STEMI) patients with intermediate to high-risk (RISK-PCI score >3) clinical features undergoing PPCI will be randomly allocated to treatment modification or standard treatment. Low responders to aspirin will receive 200 mg aspirin for 30 days. Low responders to clopidogrel will receive 180 mg ticagrelor for 1 year. Patients will be followed up to 1 year after PPCI.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Centre of Serbia
• Treatments: Aspirin; Ticagrelor

Criteria

Inclusion Criteria:

• 18 years and older, willing consent, undergoing primary PCI for STEMI, within 12 hours of the onset of symptoms, stent implanted successfully, RISK-PCI score for 30-day MACE >3, alive 24 hours after loading doses, ability to comply with study protocol, negative pregnancy test for women of childbearing potential before enrollment, agree to use a reliable method of birth control during the study

Exclusion Criteria:

• Pre-procedural

• history of hemorrhagic stroke

• ischemic stroke within 30 days of randomization

• evidence of active abnormal bleeding within 3 months of randomization

• high risk for bleeding on long-term antiplatelet therapy

• current therapy with coumadin anticoagulant

• Pregnancy or nursing

• current enrollment in another investigational study Procedural

• balloon angioplasty without stent placement

• unsuccessful PPCI (post-procedural TIMI flow 0) Post-procedural

• active bleeding

• hemoglobin <10 g/dL or drop in hemoglobin by ≥3 g/dL

• platelet count <100 000 x 10-9/L.

• TRAP value <500 aggregation units

• indication for permanent anticoagulant therapy

• need for urgent surgical revascularization

• vascular pseudoaneurysm