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TAILOR Trombocytes And IndividuaLization of ORal antiplatelet treatment after percutaneous coronary intervention (Trombocytter og individualiseret oral antitrombotisk behandling efter perkutan koronar intervention - TAILOR

TAILOR Trombocytes And IndividuaLization of ORal antiplatelet treatment after percutaneous coronary intervention (Trombocytter og individualiseret oral antitrombotisk behandling efter perkutan koronar intervention - TAILOR

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-018235-17-DK
Enrollment
200
Registered
2010-03-03
Start date
2010-04-16
Completion date
Unknown
Last updated
2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patientens undergoing elective, subacute or acute percutaneous coronary intervention (PI) MedDRA version: 12.1 Level: LLT Classification code 10028601 Term: Myocardial ischemia

Interventions

Trade Name: Plavix Product Name: Plavix Pharmaceutical Form: Tablet INN or Proposed INN: CLOPIDOGREL CAS Number: 113665-84-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration

Sponsors

Rigshospitalet
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients scheduled for coronary angiography and percutaneous coronary intervention at Rigshospitalet are subjects to screening. Response to already initiated antithrombotic treatment therapy is evaluated by MULTIPLATE analysis. Only “low-responders” by local laboratory cut off definition– an estimated 20% of the screened patients- are subject to randomization. The patients have to be 18 years or older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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

Exclusion criteria

Exclusion criteria: Incapabel of giving informend consent Intolerance to either clopidogrel or prasugrel Need for concomitant coumadin treatment No a Danish citizen

Design outcomes

Primary

MeasureTime frame
Main Objective: To implement platelet function screening by MULTIPLATE analysis as a routine evaluation in all patients undergoing PCI. ;Secondary Objective: To evaluate whether a strategy of switching to a different drug Efient is superior to increasing maintenance dose of Plavix with regards to improving platelet inhibition. The primary endpoint would be platelet inhibition at 30 days after inclusion in the trial. Secondary endpoints would be the combination of death, non-fatal myocardial infarction or stroke at 90 days and 12 months and bleeding episodes at 90 days and 12 months. ;Primary end point(s): Trombocyte inhibition by Multiplate analysis at 30 days—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026