Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-24 @ 3:38 PM
NCT ID:
NCT01177592
Brief 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) and post-PCI VerifyNow maintenance testing will occur at 2 weeks, 3 months, and 6 months for patients in the guided therapy group. VerifyNow testing, adverse event occurrence and drug compliance will be performed as part of follow-up. Patients having a measurement of ≥ 230 PRU at 2 weeks or the 3 month visit will be reloaded with 60 mg prasugrel and receive standard maintenance dosing thereafter until the 6-month visit. Patients in guided and control study arms will return at 6 months for clinical follow-up and VerifyNow testing. After completing 6 months of the study treatment period, further antiplatelet therapy will be at the physician's discretion. At 1 year, study subjects will be contacted via phone for clinical assessment and antiplatelet compliance. Physicians adjudicating events will be blinded to the therapy assignment.
Study:
NCT01177592
Study Brief:
Protocol Section:
NCT01177592