Comparing two drug treatments for heart attack patients
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.
This study tests which of two different drug treatments helps heart attack patients manage bleeding and clotting risks better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT05116995 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of two different drug treatment strategies on bleeding and clotting risk in patients with a history of heart attack. Participants will be randomized to receive either ticagrelor followed by rivaroxaban or vice versa, with washout periods in between. Blood samples will be collected at various time points to assess safety and efficacy markers. The goal is to determine which treatment regimen is more effective in managing hemostasis in chronic coronary syndrome patients.
Who should consider this trial
Good fit: Ideal candidates are patients with chronic coronary syndrome who are at least one year post-myocardial infarction and on aspirin monotherapy with additional risk factors.
Not a fit: Patients with severe renal impairment, bleeding disorders, or recent history of significant bleeding events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with chronic coronary syndrome, enhancing their safety and outcomes.
How similar studies have performed: Other studies have explored dual antiplatelet and antithrombotic therapies, but this specific approach is novel in its comparative analysis of treatment sequences.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Halifax, Nova Scotia
- Nova Scotia Health — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Study coordinator: David M Fillmore, BSc
- Email: david.fillmore@nshealth.ca
- Phone: 9024737417
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.