Differential EFfects of Dual antIplatelet and Dual aNtithrombotic thErapy on Hemostasis in Chronic Coronary Syndrome Patients

(DEFINE CCS Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Nova Scotia Health Authority

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The investigators will be comparing the effects of two different drug treatment strategies, in patients with history of a heart attack, on different markers of bleeding and clotting risk. Both treatment strategies are already approved for the indication of improving outcomes in high-risk patients with history of heart attack.

Eligibility Criteria

Inclusion Criteria

Patients with chronic coronary syndrome (at least 1 year after having a myocardial infarction) on aspirin monotherapy will be eligible for this study.

Diabetes

Diffuse coronary artery disease.

Exclusion Criteria

Severe renal impairment (eGFR < 30 ml/unit/1.73 m2)

You have experienced a bleeding problem in your stomach or intestines within the past 6 months.

Anemia (hemoglobin < 10 g/dL)

Participant Groups

Group I: Ticagrelor first Active Control 2 Interventions

Patients will be treated with ticagrelor 60 mg twice a day for one week then on Day 21, will be treated with rivaroxaban 2.5 mg twice a day for one week.

Group II: Rivaroxaban first Active Control 2 Interventions

Patients will be treated with rivaroxaban 2.5 mg twice a day for one week then on Day 21, will be treated with ticagrelor 60 mg twice a day for one week.

Rivaroxaban is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Xarelto for:

• Deep vein thrombosis (DVT)
• Venous thromboembolism (VTE)
• Stroke prevention in non-valvular atrial fibrillation
• Prevention of VTE in patients undergoing knee or hip replacement surgery

🇪🇺 Approved in European Union as Xarelto for:

• Deep vein thrombosis (DVT)
• Venous thromboembolism (VTE)
• Stroke prevention in non-valvular atrial fibrillation
• Prevention of VTE in patients undergoing knee or hip replacement surgery
• Prevention of atherothrombotic events in patients with acute coronary syndrome

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Nova Scotia Health Halifax, Canada

Who Is Running the Clinical Trial?

Nova Scotia Health Authority Lead Sponsor

References