NIRS Ticagrelor Evaluation
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ticagrelor
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patiens Discharged on Ticagrelor
Arm Description
Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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- α 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.
Full Information
NCT ID
NCT02282332
First Posted
October 15, 2014
Last Updated
March 11, 2021
Sponsor
Medstar Health Research Institute
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT02282332
Brief Title
NIRS Ticagrelor Evaluation
Official Title
The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by Near-Infrared Spectroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
Collaborators
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patiens Discharged on Ticagrelor
Arm Type
Experimental
Arm Description
Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months.
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Primary Outcome Measure Information:
Title
Change From Baseline Lipid Pool to Follow up as Assessed by NIRS/IVUS With Treatment of Ticagrelor
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change From Baseline Inflammatory Markers to Follow up With Treatment of Ticagrelor
Description
We expect to see a significant reduction of inflammatory markers of Hs-CRP, MCP-1, IL-1, IL-6, IL-18, and TNF- α 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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
NIRS Ticagrelor Evaluation
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