Overview

Personalization of Long-Term Antiplatelet Therapy - RAPID EXTEND

Status:
Suspended
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
Summary
In patients after myocardial infarction (MI) (heart attacks) and treated with percutaneous coronary intervention (PCI), the current standard is dual antiplatelet therapy (DAPT), with aspirin and a P2Y12 receptor inhibitor, for 1 year of treatment. At 1 year, there are several options including: i) Ongoing DAPT (with aspirin and ticagrelor), ii) Selective treatment use of a P2Y12 inhibitor based on risk profiles. This study is a pilot vanguard study to evaluate several strategies for choosing anti-platelet regimen among patients post MI and PCI at 1 year.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Treatments:
Adenosine
Aspirin
Clopidogrel
Ticagrelor
Ticlopidine
Criteria
Inclusion Criteria:

- >50 years old at 1-year after myocardial infarction (non-ST-elevation myocardial
infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI)) during which they
had percutaneous coronary intervention (PCI)

- Compliant with dual antiplatelet therapy (DAPT) for ≥ 1 year without an ischemic or
bleeding complication after PCI

- Still on DAPT regimen at enrollment

- Patients must have 1 of the following atherothrombotic risk enrichment criteria:

i) Age≥ 65 years ii) Diabetes iii) 2nd Prior MI (>1 year ago) iv) multi-vessel
coronary disease v) creatinine clearance (CrCl) <60 mL/min.

Exclusion Criteria:

- Intolerance to ticagrelor or clopidogrel

- >18 months post percutaneous coronary intervention (PCI) and myocardial infarction
(MI)

- Requirement of a P2Y12 inhibitor

- Requirement of oral anticoagulation

- Take concurrent CYP3A inducing drugs which may interact with ticagrelor (e.g.
anti-epileptic drugs)

- History of stroke, TIA or intracranial bleed

- Recent GI bleed or major surgery

- Life expectancy of < 1 year

- Platelet count < 100,000/μl

- Bleeding diathesis

- On dialysis

- Severe liver disease

- At risk for bradycardia.