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Clinical Trials/EUCTR2013-003125-28-NL
EUCTR2013-003125-28-NL
Active, not recruiting
Phase 1

Antiplatelet therapy for patients undergoing transcatheter aortic valve implantation - POPular-TAVI

St. Antonius Hospital0 sites2,200 target enrollmentNovember 7, 2013
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ConditionsAortic stenosis for which a transcatheter aortic valve implantation (TAVI) is performed.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsPlavix

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Aortic stenosis for which a transcatheter aortic valve implantation (TAVI) is performed.
Sponsor
St. Antonius Hospital
Enrollment
2200
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 7, 2013
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Heart team agrees on indication and treatment proposal;
  • •2\.Patient has provided written informed consent;
  • •1\.Heart team agrees on indication and treatment proposal;
  • •2\.Need for long\-term oral anticoagulation;
  • •3\.Patient has provided written informed consent.
  • •1\.Heart team agrees on indication and treatment proposal;
  • •2\.Patient has provided written informed consent.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) no

Exclusion Criteria

  • •1\.Need for long\-term oral anticoagulation;
  • •2\.Drug\-eluting stent implantation within 3 months prior to TAVI procedure;
  • •3\.Bare\-metal stent implantation within 1 month prior to TAVI procedure;
  • •4\.Allergy or intolerance to aspirin or clopidogrel.
  • •1\.Drug\-eluting stent implantation within 3 months prior to TAVI procedure;
  • •2\.Bare\-metal stent implantation within 1 month prior to TAVI procedure;
  • •3\.Allergy or intolerance to clopidogrel.
  • •1\.Patient is younger than 65 years old;
  • •2\.Combination surgical procedure.

Outcomes

Primary Outcomes

Not specified

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