NIRS Ticagrelor Evaluation

MedStar Health

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: Ticagrelor

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02282332

AZ_ISSBRIL0304

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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