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Anticoagulant
Differential EFfects of Dual antIplatelet and Dual aNtithrombotic thErapy on Hemostasis in Chronic Coronary Syndrome Patients (DEFINE CCS Trial)
Phase 4
Recruiting
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved
Approved for 20 Other Conditions
No Placebo-Only Group
Summary
This trial will compare two drug treatments in heart attack survivors to see which one has fewer risks of bleeding/clotting. Both treatments are already approved for heart attack patients.
Eligible Conditions
- Heart Attack
- Blood Clot
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bleeding time
Secondary study objectives
Differential effects on fibrin clot lysis time
Differential effects on inflammatory markers (white cell count and CRP)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Ticagrelor firstActive Control2 Interventions
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 II: Rivaroxaban firstActive Control2 Interventions
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.
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Who is running the clinical trial?
Nova Scotia Health AuthorityLead Sponsor
288 Previous Clinical Trials
94,532 Total Patients Enrolled