CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 5,276 enrolled
Drug / intervention
Clopidogrel +1 moredrug
Likely dose
Clopidogrel 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01742117
NCT01742117Phase 4Completed

Tailored Antiplatelet Initiation to Lesson Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI)

Mayo Clinic·interventional·Posted Dec 5, 2012·Updated Nov 9, 2021

In Brief

A Phase 4 clinical trial evaluating Clopidogrel and Ticagrelor for Coronary Artery Disease and 2 related conditions. Completed, enrolled 5,276 participants across 41 sites in 4 countries.

Detailed Summary

Clopidogrel is an anti-platelet medication approved by the U.S. Federal Drug Administration (FDA) for use in patients who undergo Percutaneous Coronary Intervention (PCI) with coronary stent implantation. Anti-platelet medications work to prevent blood clots from forming. Some studies have suggested that patients who have a certain genetic liver enzyme abnormality (known as cytochrome P450 2C19 \[CYP2C19\] \*2 or \*3 allele) may have a reduced ability to activate clopidogrel, and therefore may have a lowered response to clopidogrel. It is thought that perhaps people who have a coronary stent procedure may have this genetic liver enzyme abnormality. There is a research genetic test available to determine whether or not someone has this genetic liver enzyme abnormality. Ticagrelor, is a newer anti-platelet drug that is not dependent on the CYP2C19 liver enzyme for its activation and hence in poor clopidogrel metabolizers, alternative drugs like Ticagrelor have been recommended for use as an anti-platelet agent after PCI. The purpose of this study is to determine if genetic testing can identify the best anti-platelet therapy, for patients who undergo a coronary stent placement and do not activate clopidogrel very well.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Mexico, South Korea, United States

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 5, 2012
Enrollment StartMay 1, 2013
Primary CompletionOct 31, 2020
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 13.6 years ago

Interventions

Clopidogreldrug

One 75 mg tablet per day by mouth for one year

Ticagrelordrug

One 90 mg tablet twice per day by mouth for one year