Differential EFfects of Dual antIplatelet and Dual aNtithrombotic thErapy on Hemostasis in Chronic Coronary Syndrome Patients: Define CCS Study, a Prospective Randomized Crossover Clinical Trial.
Overview
- Phase
- Phase 4
- Intervention
- Rivaroxaban
- Conditions
- Thrombosis
- Sponsor
- Nova Scotia Health Authority
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Bleeding time
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
The investigators will enroll patients with coronary disease \>1 year after an acute coronary syndrome. Subjects will be randomized to one of two treatment plans. One plan the participant will take ticagrelor for one week, then take two weeks off with no drug (washout period), then one week of rivaroxaban. The other plan will be reverse order where the participant will take rivaroxaban for one week, then two weeks off(washout period), then one week of ticagrelor. Study drugs will be provided to participants at the start of each treatment period. Bleeding time will be determined and blood samples will be taken at four timepoints (baseline, post first drug, pre second drug, and post second drug) to measure complete blood count, CRP, and fibrin clot assessment. These are surrogate markers for safety (bleeding) and efficacy (increased thrombotic risk)
Investigators
Wael Sumaya
Interventional Cardiologist
Nova Scotia Health Authority
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. They have to have at least one of these additional risk factors:
- •Diffuse coronary artery disease.
- •Peripheral vascular disease
- •Chronic kidney disease (eGFR\<60 ml/unit/1.73 m2)
Exclusion Criteria
- •Allergy to either rivaroxaban or ticagrelor
- •Requirement for anticoagulation or P2Y12 inhibitor therapy
- •Anemia (hemoglobin \< 10 g/dL)
- •Severe renal impairment (eGFR \< 30 ml/unit/1.73 m2)
- •Bleeding disorders
- •Significant liver impairment resulting in deranged clotting parameters
- •Any history of intracranial hemorrhage
- •Stroke within 6 months
- •History of gastrointestinal bleed within 6 months
- •Major surgery within 1 month
Arms & Interventions
Rivaroxaban first
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.
Intervention: Rivaroxaban
Rivaroxaban first
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.
Intervention: Ticagrelor
Ticagrelor first
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.
Intervention: Rivaroxaban
Ticagrelor first
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.
Intervention: Ticagrelor
Outcomes
Primary Outcomes
Bleeding time
Time Frame: 7 days
The primary objective is to determine the differential effect of rivaroxaban and ticagrelor on bleeding time as a surrogate marker for bleeding tendency.
Secondary Outcomes
- Differential effects on inflammatory markers (white cell count and CRP)(7 days)
- Differential effects on fibrin clot lysis time(7 days)