Phase 4 N=30 Prevention

NIRS Ticagrelor Evaluation

Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT02282332 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Apr 2021

Primary outcome: Primary: Change From Baseline Lipid Pool to Follow up as Assessed by NIRS/IVUS With Treatment of Ticagrelor

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ticagrelor (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medstar Health Research Institute
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline Lipid Pool to Follow up as Assessed by NIRS/IVUS With Treatment of Ticagrelor	—	—
SECONDARY Change From Baseline Inflammatory Markers to Follow up With Treatment of Ticagrelor	—	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02282332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.