NIRS Ticagrelor Evaluation

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medstar Health Research Institute
• Collaborator: AstraZeneca
• Treatments: Ticagrelor

Criteria

Inclusion Criteria:

• • Female (post menopausal or surgically sterile) and/or male aged 18 years or older

• Multi-vessel coronary artery disease CAD

• 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 severe hepatic impairment

• Known hypersensitivity to ticagrelor