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

• Sponsor: Nova Scotia Health Authority (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05116995
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thrombosis; Myocardial Infarction	Drug: Rivaroxaban; Drug: Ticagrelor	Phase 4

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)

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Treatment #1 for one week then on Day 21 they enter Treatment #2 for 1 week.Treatment #1 for one week then on Day 21 they enter Treatment #2 for 1 week.
• Masking: Single (Care Provider)
• Masking Description: Study personnel performing bleeding time and laboratory staff will be blinded to treatment allocation.
• Primary Purpose: Treatment
• 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.
• Anticipated Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Rivaroxaban; rivaroxaban 2.5 mg twice a day for 7 days; Other Names: xarelto ; Drug: Ticagrelor; Ticagrelor 60 mg twice a day for 7 days; Other Names: brilinta
Active Comparator: 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.	Drug: Rivaroxaban; rivaroxaban 2.5 mg twice a day for 7 days; Other Names: xarelto ; Drug: Ticagrelor; Ticagrelor 60 mg twice a day for 7 days; Other Names: brilinta

Outcome Measures

Primary Outcome Measures

1. Bleeding time [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 Outcome Measures

1. Differential effects on inflammatory markers (white cell count and CRP) [7 days]

   These will be measured from blood draws

2. Differential effects on fibrin clot lysis time [7 days]

   This will be measured from blood draws

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nova Scotia Health Authority

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wael Sumaya, Interventional Cardiologist, Nova Scotia Health Authority
• ClinicalTrials.gov Identifier: NCT05116995
• Other Study ID Numbers: SUM001
• First Posted: Nov 11, 2021
• Last Update Posted: Nov 11, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myocardial Infarction; Thrombosis; Infarction; Rivaroxaban; Ticagrelor

Study Results

No Results Posted as of Nov 11, 2021