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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282332
• Other study ID #: AZ_ISSBRIL0304
• Status: Completed
• Phase: Phase 4
• Start date: June 2014
• Est. completion date: April 2016

Study information

• Verified date: March 2021
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• Ticagrelor

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Health Research Institute	AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Lipid Pool to Follow up as Assessed by NIRS/IVUS With Treatment of Ticagrelor	Treatment with ticagrelor following PCI will lead to significant 20% reduction in the LCBI as assessed at follow up by NIRS/IVUS when compared with baseline imaging data of the reference vessel, suggesting a reduction in inflammation and stabilization of the lipid core in atherosclerotic lesions not treated during the index procedure.	6 months
Secondary	Change From Baseline Inflammatory Markers to Follow up With Treatment of Ticagrelor	We expect to see a significant reduction of inflammatory markers of Hs-CRP, MCP-1, IL-1, IL-6, IL-18, and TNF- a as well as an increase in IL-10, a cytokine associated with a reduction in inflammation, following therapy with ticagrelor when compared with baseline values. This is expected as inflammatory markers should be lower in stable coronary artery disease compared with patients presenting with ACS. While there is no control group in the proposed study, it will be important to assess whether changes in established biomarkers associated with inflammation correlate with changes in LCBI. While ticagrelor was not shown to reduce inflammatory biomarkers to a greater degree than clopidogrel, it will be important to assess whether the reduction in LCBI is independent of or associated with reductions in inflammatory markers or platelet reactivity.	6 months