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

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

St. Antonius Hospital0 sites1,000 target enrollmentApril 10, 2017
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ConditionsAortic stenosis for which a transcatheter aortic valve implantation (TAVI) is performed.MedDRA version: 19.1Level: PTClassification code 10002906Term: Aortic stenosisSystem Organ Class: 10047065 - Vascular disordersTherapeutic 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
1000
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 10, 2017
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Patient has provided written informed consent.
  • •1\.Need for long\-term oral anticoagulation;
  • •2\.Patient has provided written informed consent.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range 0
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 1000

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 or contraindication 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\.Use of non\-vitamin K oral anticoagulation (NOAC).
  • •4\.Allergy or intolerance or contraindication to OAC or clopidogrel.

Outcomes

Primary Outcomes

Not specified

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