NIRS Ticagrelor Evaluation

Coronary Artery Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Coronary Artery Disease

• NCT number: NCT02282332
• Study type: Interventional
• Source: Medstar Health Research Institute
• Status: Completed
• Phase: Phase 4
• Start date: June 2014
• Completion date: April 2016