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

Launched by NOVA SCOTIA HEALTH AUTHORITY · Nov 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how two different drug treatment strategies affect bleeding and clotting risks in patients who have a history of heart attacks. Both treatment options are already approved for helping patients at high risk after a heart attack. The goal is to better understand which treatment may be safer and more effective for patients with chronic coronary syndrome, which means they have ongoing heart issues at least one year after their heart attack.

To participate in this study, patients need to have been on aspirin alone for at least one year and have additional risk factors like diabetes, kidney disease, or issues with their blood vessels. The study is currently looking for participants of all genders, aged 20 years or older. If eligible, participants can expect to receive one of the two treatments and will be monitored for any changes in bleeding or clotting. It’s important to note that some individuals, such as those with certain health conditions or who are pregnant, may not be able to join the trial. This research aims to improve treatment options for patients who have experienced a heart attack and help doctors provide the best care possible.

Gender

ALL

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:
• • 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