search
Back to results

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

Primary Purpose

Thrombosis, Myocardial Infarction

Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Rivaroxaban
Ticagrelor
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombosis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nova Scotia HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rivaroxaban first

Ticagrelor first

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Differential effects on inflammatory markers (white cell count and CRP)
These will be measured from blood draws
Differential effects on fibrin clot lysis time
This will be measured from blood draws

Full Information

First Posted
October 21, 2021
Last Updated
September 21, 2023
Sponsor
Nova Scotia Health Authority
search

1. Study Identification

Unique Protocol Identification Number
NCT05116995
Brief Title
Differential EFfects of Dual antIplatelet and Dual aNtithrombotic thErapy on Hemostasis in Chronic Coronary Syndrome Patients
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis, Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Treatment #1 for one week then on Day 21 they enter Treatment #2 for 1 week.
Masking
Care Provider
Masking Description
Study personnel performing bleeding time and laboratory staff will be blinded to treatment allocation.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban first
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ticagrelor first
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
xarelto
Intervention Description
rivaroxaban 2.5 mg twice a day for 7 days
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
brilinta
Intervention Description
Ticagrelor 60 mg twice a day for 7 days
Primary Outcome Measure Information:
Title
Bleeding time
Description
The primary objective is to determine the differential effect of rivaroxaban and ticagrelor on bleeding time as a surrogate marker for bleeding tendency.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Differential effects on inflammatory markers (white cell count and CRP)
Description
These will be measured from blood draws
Time Frame
7 days
Title
Differential effects on fibrin clot lysis time
Description
This will be measured from blood draws
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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: Diffuse coronary artery disease. Peripheral vascular disease Diabetes 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David M Fillmore, BSc
Phone
9024737417
Email
david.fillmore@nshealth.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Wael Sumaya, PhD
Phone
9024735769
Email
wael.sumaya@nshealth.ca
Facility Information:
Facility Name
Nova Scotia Health
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David M Fillmore, BSc
Phone
902-473-7417

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs