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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT02282332
Brief Summary:
The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by Near-Infrared Spectroscopy study will evaluate whether ticagrelor leads to a 20% reduction in the LCBI with NIRS/IVUS suggesting coronary plaque stabilization and reduced inflammation in patients already on long-term statin therapy undergoing non-urgent PCI. It is hypothesized that the treatment with ticagrelor following PCI will lead to a significant 20% reduction in the lipid pool as measured by NIRS/IVUS at follow-up when compared with baseline imaging, suggesting a reduction in inflammation and stabilization of the lipid core in atherosclerotic lesions not treated during the index procedure.
Detailed Description:
Single-Center, open-label study of the effect of ticagrelor on the reduction in the lipid pool in 30 patients with multi-vessel CAD 2 Treatment periods over 6 months, with 2 additional follow-up phone calls at 1 and 3 months.
Non-urgent PCI requiring stent placement and evaluation by NIRS/IVUS at baseline and 6 month follow up A second concomitant coronary lesion with diameter stenosis greater than 50% will also be imaged using NIRS/IVUS.
Patients will be discharged on a ticagrelor regiment of 90 mg twice a day for the 6 month study.
Blood samples will be drawn at baseline prior to ticagrelor being administered and again at follow up.
Inclusion Criteria:
* Female (post menopausal or surgically sterile) and/or male aged 18 years or older
* Multi-vessel coronary artery disease
* Statin therapy for minimum of 6 weeks prior to enrollment in the study with no plan for further adjustment
* Non-emergent PCI for ACS with stent placement requiring dual-antiplatelet therapy
* Ability to safely perform NIRS/IVUS for a concomitant non-culprit lesion with diameter stenosis ≥ 50% that was not treated with PCI
* Willing and able to sign informed consent and participate in follow-up
Exclusion Criteria:
* Thienopyridine or ticagrelor use in the last month
* Need for coronary artery bypass surgery or other surgeries during the follow-up period
* Documented medication non-compliance
* Chronic inflammatory disorder or treatment with anti-inflammatory or immunosuppressive drugs
* Prior or current malignancy within the last 5 years
* Concomitant severe illness or reduced life expectancy that will prevent follow-up cardiac catheterization
* Active infection
* Pregnant or lactating women
* End-stage renal disease
* History of intracranial hemorrhage
* Active pathological bleeding
* Known sever hepatic impairment
* Known hypersensitivity to ticagrelor
Study Procedures:
After consent is obtained non-urgent PCI requiring stent placement and evaluation by NIRS/IVUS at baseline is performed and once again at 6 month follow up. A second concomitant coronary lesion with diameter stenosis greater than 50% will also be imaged using NIRS/IVUS. Patients will be discharged on a ticagrelor regiment of 90 mg twice a day for the 6 month study.Blood samples will be drawn at baseline prior to ticagrelor being administered and again at follow up. There will be 1 month phone follow up, 3 month phone follow up and a 6 month clinical follow up that includes collecting blood, repeat catheterization, and repeat NIRS/IVUS procedure.
Study:
NCT02282332
Study Brief:
Protocol Section:
NCT02282332