NIRS Ticagrelor Evaluation

NCT02282332 | Completed Phase 4 Results

• 1 other identifier: AZ_ISSBRIL0304
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Change From Baseline Inflammatory Markers to Follow up With Treatment of Ticagrelor

  6 months

Study Arms (1)

Patiens Discharged on Ticagrelor

EXPERIMENTAL

Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months.

Drug: Ticagrelor

Interventions

Ticagrelor DRUG

Patiens Discharged on Ticagrelor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• AstraZeneca: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Scientific Center Adminstrator
• Organization: MedStar Health Research Institute

Research@medstar.net

(301) 560-7300

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: November 4, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 8, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-03