A Novel Strategy For Personalized Long-Term Dual Antiplatelet Therapy (RAPID EXTEND PILOT STUDY)

NCT ID: NCT03224923

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-18
• Study Completion Date: 2018-09-30

Brief Summary

In patients with heart attacks, the current standard of care is to restore blood flow through percutaneous coronary intervention (PCI). This is done using stents (metal meshes) that opens up blockages. Following PCI, standard preventative drug treatment includes the use of dual antiplatelet therapy (DAPT) using both aspirin and a platelet P2Y12 receptor inhibitor (Ticagrelor 90 mg twice a day or Clopidogrel 75 mg once a day) for one year to prevent clotting that can result in additional heart attacks, sudden clotting of stents or death.

New studies have shown that there is a benefit to continuing DAPT beyond this one year mark. Longer-term DAPT has been shown to reduce ischemic events (heart attack, stroke) but increase the risk of bleeding. Present guidelines state that the decision to continue DAPT beyond the one year mark should be made on an individualized basis.

The present study is a "pilot study" that seeks to compare Long-Term use of Ticagrelor (LTT) versus a Personalized Approach (PA). We will be recruiting patients who have been stable (free of ischemic or bleeding outcomes) on DAPT for 1 year after initial presentation with a heart attack.

The PA group will use a modified DAPT score based on patient demographics to decide whether treatment is warranted. Patient will also undergo bedside genetic testing to identify potential at-risk genes. Those identified as carriers will be treated with ticagrelor while non-carriers will be treated with clopidogrel.

The present study will determine whether a personalized approach will decrease bleeding versus an approach of universal ticagrelor use.

The hypothesis is that patients receiving a personalized strategy will have a decreased risk of bleeding.

Conditions

Stable Coronary Syndrome; Percutaneous Coronary Intervention; Antiplatelet Therapy; Ticagrelor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Personalized Treatment Algorithm

A DAPT score using various patient demographics will be calculated:

If score under 2, patients will receive only aspirin 81 mg once daily

If DAPT score is ≥ 2

• A point-of-care bedside genetic test using a buccal swab will be conducted in order to determine medication regimen
• Those with a positive genetic test (presence of CYP2C19*2 or CYP2C19*3), will receive 60mg Ticagrelor twice daily
• Those with a negative genetic test (absence of CYP2C19*2/*3) will receive 75mg clopidogrel once daily

Group Type: EXPERIMENTAL

Ticagrelor 60mg

Intervention Type: DRUG

twice daily

Clopidogrel 75mg

Intervention Type: DRUG

once daily

Aspirin 81 mg

Intervention Type: DRUG

once daily

Long-Term Ticagrelor

Patients will be given 60mg Ticagrelor twice daily with no aspirin

Group Type: ACTIVE_COMPARATOR

Ticagrelor 60mg

Intervention Type: DRUG

twice daily

Interventions

Ticagrelor 60mg

twice daily

Intervention Type: DRUG

Clopidogrel 75mg

once daily

Intervention Type: DRUG

Aspirin 81 mg

once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI) at presentation for index PCI who have successfully completed >1-year follow-up of RAPID MANAGE or TAILOR-PCI trials without having incurred an ischemic or bleeding outcome while on DAPT
• Patients with DAPT interruption after 1 year will be eligible, if within 3 years of index MI

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

• age ≥ 65 years
• diabetes
• 2nd prior MI (> 1 year ago)
• multi-vessel coronary disease
• Creatinine Clearance < 60mL/min

Exclusion Criteria

Patients will be excluded from the study if they:

• refuse consent
• are > 3 years post MI
• are deemed to require a P2Y12 inhibitor
• require oral anticoagulation
• have a history of stroke, transient ischemic attack (TIA) or intracranial bleed
• have had a recent GI bleed or major surgery
• have a life expectancy of < 1 year
• have a platelet count < 100,000/μl
• have a bleeding diathesis
• have hematocrit < 30% or > 52%
• are on dialysis or have severe liver disease
• are at risk for bradycardia

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Derek So, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20170341

Identifier Type: -

Identifier Source: org_study_id