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Antiplatelet Agent
Clopidogrel for Coronary Artery Disease (ISAR-SAFE Trial)
Phase 4
Waitlist Available
Led By Jurriёn M ten Berg, MD
Research Sponsored by Deutsches Herzzentrum Muenchen
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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
Pivotal Trial
Summary
The purpose of this study is to determine whether a 6 month duration of clopidogrel therapy after DES implantation is not inferior to that of a 12 month therapy.
Eligible Conditions
- Coronary Artery Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ClopidogrelActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
Deutsches Herzzentrum MuenchenLead Sponsor
119 Previous Clinical Trials
83,961 Total Patients Enrolled
27 Trials studying Coronary Artery Disease
29,305 Patients Enrolled for Coronary Artery Disease
Adnan Kastrati, MDStudy ChairDeutsches Herzzentrum Muenchen
32 Previous Clinical Trials
34,069 Total Patients Enrolled
12 Trials studying Coronary Artery Disease
19,230 Patients Enrolled for Coronary Artery Disease
Jurriёn M ten Berg, MDPrincipal InvestigatorSt. Antonius Hospital Nieuwegein, Department of Cardiology
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