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Prasugrel Versus Double Dose Clopidogrel to Treat Clopidogrel Low-responsiveness After PCI

Thrombocytes And IndividuaLization of ORal Antiplatelet Treatment After Percutaneous Coronary Intervention

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01135667
Acronym
TAILOR
Enrollment
106
Registered
2010-06-03
Start date
2010-09-30
Completion date
2012-08-31
Last updated
2012-10-04

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

Conditions

Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndromes

Keywords

clopidogrel, prasugrel, low responder, multiplate, verify now

Brief summary

All patients undergoing elective or sub-acute PCI are screened by MULTIPLATE test for clopidogrel low-responsiveness after receiving 600 mg clopidogrel the day before. A cut off value has previously been established. Only low-responders with Multiplate values above the cut off value are included in the study. The patients are randomized to either clopidogrel 150 mg once daily or Prasugrel 10 mg (age \> 75 og bodyweight \< 60 kg 5 mg)once daily for 30 days after the procedure. Follow up will be at 30 days after PCI were another MULTIPLATE test will be performed. Primary endpoint:Platelet inhibition (by MULTIPLATE) after 30 days of intensified antiplatelet therapy. Clinical endpoints such as bleeding complications (GUSTO, TIMI) during treatment, and major adverse cardiac events (MACE) at 30 days will be collected and reported but the study size does not allow for formal statistical analysis The study ends by the 30 days follow up visit and all patients continue with clopidogrel 75 mg once daily for another 11 months (not study related)

Interventions

DRUGclopidogrel

clopidogrel 150 mg once daily for 30 days

Prasugrel 10 mg once daily for 30 days

Sponsors

Lene Holmvang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* PCI with stenting and Multiplate hep-ADP \> 70 U despite clopidogrel loading

Exclusion criteria

* need for vit K antagonist * women with childbearing potential * breastfeeding women * Planned surgery within 6 months * Intolerance to clopidogrel, prasugrel or aspirin * previous stroke

Design outcomes

Primary

MeasureTime frameDescription
Heparin ADP by Multiplate30 daysTest of platelet inhibition (ADP receptor mediated) after 30 days of intensifiet anti platelet therapy

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026