NIRS Ticagrelor Evaluation

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.

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