NCT02282332

NIRS Ticagrelor Evaluation

The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by Near-Infrared Spectroscopy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Ticagrelor

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-11-04
• Last updated: 2021-04-08
• Results posted: 2021-04-08