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

Myocardial Infarction Clinical Trial

— DEFINE CCS  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05116995
• Other study ID #: SUM001
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: September 2023
• Source: Nova Scotia Health Authority
• Contact: David M Fillmore, BSc
• Phone: 9024737417
• Email: david.fillmore[@]nshealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Thrombosis

Intervention

Drug:
• Rivaroxaban
rivaroxaban 2.5 mg twice a day for 7 days
• Ticagrelor
Ticagrelor 60 mg twice a day for 7 days

Locations

Country	Name	City	State
Canada	Nova Scotia Health	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding time	The primary objective is to determine the differential effect of rivaroxaban and ticagrelor on bleeding time as a surrogate marker for bleeding tendency.	7 days
Secondary	Differential effects on inflammatory markers (white cell count and CRP)	These will be measured from blood draws	7 days
Secondary	Differential effects on fibrin clot lysis time	This will be measured from blood draws	7 days