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

NCT ID: NCT05116995

Last Updated: 2023-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-11-01

Brief Summary

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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

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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)

Conditions

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Thrombosis Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Treatment #1 for one week then on Day 21 they enter Treatment #2 for 1 week.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers
Study personnel performing bleeding time and laboratory staff will be blinded to treatment allocation.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Rivaroxaban

Intervention Type DRUG

rivaroxaban 2.5 mg twice a day for 7 days

Ticagrelor

Intervention Type DRUG

Ticagrelor 60 mg twice a day for 7 days

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.

Group Type ACTIVE_COMPARATOR

Rivaroxaban

Intervention Type DRUG

rivaroxaban 2.5 mg twice a day for 7 days

Ticagrelor

Intervention Type DRUG

Ticagrelor 60 mg twice a day for 7 days

Interventions

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Rivaroxaban

rivaroxaban 2.5 mg twice a day for 7 days

Intervention Type DRUG

Ticagrelor

Ticagrelor 60 mg twice a day for 7 days

Intervention Type DRUG

Other Intervention Names

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xarelto brilinta

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nova Scotia Health Authority

OTHER

Sponsor Role lead

Responsible Party

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Wael Sumaya

Interventional Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nova Scotia Health

Halifax, Nova Scotia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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David M Fillmore, BSc

Role: CONTACT

9024737417

Wael Sumaya, PhD

Role: CONTACT

9024735769

Facility Contacts

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David M Fillmore, BSc

Role: primary

902-473-7417

Other Identifiers

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SUM001

Identifier Type: -

Identifier Source: org_study_id

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