Trial Outcomes & Findings for NIRS Ticagrelor Evaluation (NCT NCT02282332)
NCT ID: NCT02282332
Last Updated: 2021-04-08
Results Overview
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.
COMPLETED
PHASE4
30 participants
6 months
2021-04-08
Participant Flow
Participant milestones
| Measure |
Patiens Discharged on Ticagrelor
Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months.
Ticagrelor
|
|---|---|
|
Overall Study
STARTED
|
0
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NIRS Ticagrelor Evaluation
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 6 monthsPopulation: The PI has left the institution and no results data is available. Efforts were made to contact the PI/study team members, as well as to review data on shared drives, IRB historical records and published resources, but were unsuccessful. No study data are available
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: The PI has left the institution and no results data is available. Efforts were made to contact the PI/study team members, as well as to review data on shared drives, IRB historical records and published resources, but were unsuccessful. No study data are available
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.
Outcome measures
Outcome data not reported
Adverse Events
Patiens Discharged on Ticagrelor
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Scientific Center Adminstrator
MedStar Health Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place