Phase 4
Completed N=30
NIRS Ticagrelor Evaluation
Source: ClinicalTrials.gov NCT02282332 ↗Enrolled (actual)
30
Serious AEs
—
Results posted
Apr 2021
Primary outcomePrimary: Change From Baseline Lipid Pool to Follow up as Assessed by NIRS/IVUS With Treatment of Ticagrelor
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
— | — |
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
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. Informational only — not medical advice.