Status:
COMPLETED
NIRS Ticagrelor Evaluation
Lead Sponsor:
Medstar Health Research Institute
Collaborating Sponsors:
AstraZeneca
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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...
Eligibility Criteria
Inclusion
- • 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
- 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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02282332
Start Date
June 1 2014
End Date
April 1 2016
Last Update
April 8 2021
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