Clinical trial NCT05116995: Differential EFfects of Dual antIplatelet and Dual aNtithrombotic thErapy on Hemostasis in Chronic Coronary Syndrome Patients
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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Thrombosis
Myocardial Infarction
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Treatment #1 for one week then on Day 21 they enter Treatment #2 for 1 week.
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Bleeding time
timeFrame: 7 days
Secondary outcomes:
measure: Differential effects on inflammatory markers (white cell count and CRP)
timeFrame: 7 days
measure: Differential effects on fibrin clot lysis time
timeFrame: 7 days
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health
state: Nova Scotia
Study officials:
References: