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NCT01177592 · ClinicalTrials.gov registry record · NA
Thrombocyte Activity Reassessment and GEnoTyping for PCI(TARGET-PCI)
A NA study, sponsored by LifeBridge Health.
- Terminated
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT01177592 is a NA study that was terminated before completion, run by LifeBridge Health. The registered enrollment target is 7 participants.
The verdict
NCT01177592, a NA study, was terminated before completion, sponsored by LifeBridge Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is a prospective, single-center, randomized trial including 1500 subjects requiring PCI. Subjects with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass undergoing PCI with stent placement and no contraindication to prolonged dual antiplatelet therapy (≥1 year) are eligible to be in the study. Subjects will be randomized to either guided antiplatelet therapy arm (n=750) or standard therapy arm (n=750) and undergo laboratory testing, antiplatelet adjustment, and clinical follow-up for 1 year. Patients (non-emergent) presenting for PCI will receive standard pre-procedural PCI care as outlined by the current ACC/AHA guidelines. Subjects will be consented peri- PCI (prior to or within 24 hours of PCI) and then randomized (1:1 ratio) to guide or standard non-guided (control) antiplatelet therapy. Physicians will be blinded to genotyping and platelet function results for subjects randomized to the standard therapy group for the duration of the study or if endpoint is met. Subjects on chronic clopidogrel or prasugrel therapy (≥ 2 weeks) will be guided by VerifyNow P2Y12 assay, whereas clopidogrel naïve subjects will be guided by Verigene CYP2C19 genotyping assay. Patients on clopidogrel maintenance and/or in the control group will also be genotyped; conversely, clopidogrel naïve subjects will have VerifyNow testing prior to discharge for additional study analysis. Patients in the guided therapy group that have a measurement of ≥ 230 PRU will be reloaded with 60mg prasugrel and receive standard maintenance dosing. Similarly, clopidogrel naïve subjects that are considered CYP2C19\*2 carriers will also be reloaded with 60mg prasugrel and receive standard maintenance dosing (see flow schematic). Patients randomized to the control arm will remain on 75mg clopidogrel arm throughout the study. All patients will remain on 325mg ASA for one month and 81-162 mg daily ASA thereafter. Clinical follow-up (office visit) an
Interventions
- DEVICE VerifyNow, Verigene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2010-07 |
| Est. Completion | 2010-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01177592
The ClinicalTrials.gov registry entry for NCT01177592 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LifeBridge Health, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which VerifyNow, Verigene is the first listed.
NCT01177592 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01177592 about?
NCT01177592 is a clinical study titled "Thrombocyte Activity Reassessment and GEnoTyping for PCI(TARGET-PCI)". This is a prospective, single-center, randomized trial including 1500 subjects requiring PCI. Subjects with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass undergoing PCI with stent placement and no contraindication to prolonged dual antipl...
What is the current status of trial NCT01177592?
This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2010-07. Estimated completion is 2010-10.
What interventions are being tested in trial NCT01177592?
The interventions under investigation include: VerifyNow, Verigene (DEVICE).
Who is sponsoring clinical trial NCT01177592?
This trial is sponsored by LifeBridge Health, which has 14 total clinical trials registered on ClinicalTrials.gov.
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