Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-04 @ 10:15 PM
Study NCT ID:
NCT02282332
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2014-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
NIRS Ticagrelor Evaluation
Sponsor:
Medstar Health Research Institute
Organization:
Study Overview
Official Title:
The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by Near-Infrared Spectroscopy
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: