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
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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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2021-11-01
2023-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
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.
Rivaroxaban
rivaroxaban 2.5 mg twice a day for 7 days
Ticagrelor
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.
Rivaroxaban
rivaroxaban 2.5 mg twice a day for 7 days
Ticagrelor
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
Ticagrelor
Ticagrelor 60 mg twice a day for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Diffuse coronary artery disease.
2. Peripheral vascular disease
3. Diabetes
4. Chronic kidney disease (eGFR\<60 ml/unit/1.73 m2)
Exclusion Criteria
* 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
55 Years
ALL
No
Sponsors
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Nova Scotia Health Authority
OTHER
Responsible Party
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Wael Sumaya
Interventional Cardiologist
Locations
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Nova Scotia Health
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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David M Fillmore, BSc
Role: primary
Other Identifiers
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SUM001
Identifier Type: -
Identifier Source: org_study_id
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