NIRS Ticagrelor Evaluation

• Sponsor: Medstar Health Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02282332
• Collaborator: AstraZeneca (Industry)
• Enrollment: 30
• Arm: 1
• Duration (Months): 22

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Ticagrelor	Phase 4

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 calls at 1 and 3 months.

Non-urgent PCI requiring stent placement and evaluation by NIRS/IVUS at baseline and 6 month follow up A second concomitant coronary lesion with diameter stenosis greater than 50% will also be imaged using NIRS/IVUS.

Patients will be discharged on a ticagrelor regiment of 90 mg twice a day for the 6 month study.

Blood samples will be drawn at baseline prior to ticagrelor being administered and again at follow up.

Inclusion Criteria:

• Female (post menopausal or surgically sterile) and/or male aged 18 years or older

• Multi-vessel coronary artery disease

• 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 sever hepatic impairment

• Known hypersensitivity to ticagrelor

Study Procedures:

After consent is obtained non-urgent PCI requiring stent placement and evaluation by NIRS/IVUS at baseline is performed and once again at 6 month follow up. A second concomitant coronary lesion with diameter stenosis greater than 50% will also be imaged using NIRS/IVUS. Patients will be discharged on a ticagrelor regiment of 90 mg twice a day for the 6 month study.Blood samples will be drawn at baseline prior to ticagrelor being administered and again at follow up. There will be 1 month phone follow up, 3 month phone follow up and a 6 month clinical follow up that includes collecting blood, repeat catheterization, and repeat NIRS/IVUS procedure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by Near-Infrared Spectroscopy
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patiens Discharged on Ticagrelor Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months.	Drug: Ticagrelor

Outcome Measures

Primary Outcome Measures

1. Change From Baseline Lipid Pool to Follow up as Assessed by NIRS/IVUS With Treatment of Ticagrelor [6 months]

   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.

Secondary Outcome Measures

1. Change From Baseline Inflammatory Markers to Follow up With Treatment of Ticagrelor [6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medstar Health Research Institute
• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medstar Health Research Institute
• ClinicalTrials.gov Identifier: NCT02282332
• Other Study ID Numbers: AZ_ISSBRIL0304
• First Posted: Nov 4, 2014
• Last Update Posted: Apr 8, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Coronary Artery Disease; Ticagrelor

Study Results

Participant Flow

Arm/Group Title	Patiens Discharged on Ticagrelor
Arm/Group Description	Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months. Ticagrelor
Period Title: Overall Study
STARTED	0
COMPLETED	0
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Patiens Discharged on Ticagrelor
Arm/Group Description	Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months. Ticagrelor
Overall Participants	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male

Outcome Measures

1. Primary Outcome

Title	Change From Baseline Lipid Pool to Follow up as Assessed by NIRS/IVUS With Treatment of Ticagrelor
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Patiens Discharged on Ticagrelor
Arm/Group Description	Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months. Ticagrelor
Measure Participants	0

2. Secondary Outcome

Title	Change From Baseline Inflammatory Markers to Follow up With Treatment of Ticagrelor
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Patiens Discharged on Ticagrelor
Arm/Group Description	Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months. Ticagrelor
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	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
Arm/Group Title	Patiens Discharged on Ticagrelor
Arm/Group Description	Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months. Ticagrelor
All Cause Mortality
	Patiens Discharged on Ticagrelor
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Patiens Discharged on Ticagrelor
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Patiens Discharged on Ticagrelor
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.