Clinical trial NCT02282332: NIRS Ticagrelor Evaluation
Official title: The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by Near-Infrared Spectroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2014-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change From Baseline Lipid Pool to Follow up as Assessed by NIRS/IVUS With Treatment of Ticagrelor
timeFrame: 6 months
Secondary outcomes:
measure: Change From Baseline Inflammatory Markers to Follow up With Treatment of Ticagrelor
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: