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

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nova Scotia Health Authority
• Treatments: Rivaroxaban; Ticagrelor

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:

1. Diffuse coronary artery disease.

2. Peripheral vascular disease

3. Diabetes

4. 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

• Patients with inflammatory conditions

• Concomitant treatment with immunosuppressive therapy, inhibitors or inducers of P glycoprotein or CYP3A4 enzymes (eg. azole antifungals, ritonavir, erythromycin, clarithromycin, rifampicin)

• Concomitant treatment with antidepressants (selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors)

• Pregnancy

• Inability to give written consent