Antiplatelet therapy for patients undergoing transcatheter aortic valve implantatio

Phase 1

• Conditions: Aortic stenosis for which a transcatheter aortic valve implantation (TAVI) is performed.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-003125-28-NL
• Lead Sponsor: St. Antonius Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-07
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

Cohort A
1.Heart team agrees on indication and treatment proposal;
2.Patient has provided written informed consent;

Cohort B
1.Heart team agrees on indication and treatment proposal;
2.Need for long-term oral anticoagulation;
3.Patient has provided written informed consent.

Cohort C
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
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2200

Exclusion Criteria

Cohort A
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.

Cohort B
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.

Cohort C
1.Patient is younger than 65 years old;
2.Combination surgical procedure.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.To investigate the safety and efficacy of omission of clopidogrel during follow-up in patients without an indication for oral anticoagulation (OAC) after TAVI (Cohort A);<br>2.To investigate the safety and efficacy of omission of clopidogrel during follow-up in patients with an indication for OAC after TAVI (Cohort B);<br><br>;Secondary Objective: 1.To investigate the safety and efficacy of the studied antithrombotic treatment regimens after TAVI compared with the common practiced antithrombotic treatment after surgical aortic valve replacement (SAVR) (Cohort C);<br>2.Furthermore we obtain to investigate the effect of omission of clopidogrel on cognitive and functional parameters, quality of life and costs.;Primary end point(s): Primary safety outcome is defined as all bleeding. Co-primary safety outcome is defined as all non-procedure related bleeding. ;Timepoint(s) of evaluation of this end point: 30 days and 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary efficacy outcome is a composite of cardiovascular mortality, major bleeding, life threatening/disabling bleeding, all-cause stroke, and myocardial infarction. Co-secondary efficacy outcome is a composite of cardiovascular mortality, non-procedure related bleeding, all-cause stroke, and myocardial infarction.;Timepoint(s) of evaluation of this end point: 30 days and 12 months