NIRS Ticagrelor Evaluation

NCT ID: NCT02282332

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-04-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patiens Discharged on Ticagrelor

Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months.

Group Type: EXPERIMENTAL

Ticagrelor

Intervention Type: DRUG

Interventions

Ticagrelor

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

AZ_ISSBRIL0304

Identifier Type: -

Identifier Source: org_study_id