Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During PCI: an OCT Study

Coronary Artery Disease Clinical Trial

Official title:

Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During Percutaneous Coronary Intervention: an Optical Coherence Tomography Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01826175
• Other study ID #: 2013P000225
• Status: Withdrawn
• Phase: Phase 4
• First received: April 1, 2013
• Last updated: December 19, 2016
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: December 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Subjects with acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Subjects that are to be treated clinically with coronary artery stenting will be randomized to receive a loading dose of clopidogrel versus ticagrelor after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the presence of blood clots inside the new stent will be measured and compared between the groups.

Description:

Subjects with acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Subjects that are to be treated clinically with coronary artery stenting will be randomized to receive a loading dose of clopidogrel versus ticagrelor after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the presence of blood clots inside the new stent will be measured and compared between the groups

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

Patient Characteristics:

1. Males and non-pregnant females > 18 and < 79 years of age presenting with acute coronary syndrome defined as having two of the following criteria:

1. Signs and symptoms consistent with accelerated angina or prolonged angina (lasting greater than 20 minutes) either at rest or with minimal exertion

2. ECG changes indicative of new ischemia

3. Levels of cardiac biomarkers (troponin-T) above the upper limit of the normal range.

2. Patients scheduled to undergo coronary angiography with possible percutaneous coronary intervention (PCI)

Lesion Characteristics on Diagnostic Coronary Angiography

1. De novo lesions in native coronary arteries found by diagnostic coronary angiography

2. Angiographic stenosis <100%

3. Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation

Exclusion Criteria:

General Exclusion Criteria

1. Subjects who are unable or unwilling to sign the informed consent form

2. Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors.

3. Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study

4. Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction < 30%

5. Subjects with an ST elevation myocardial infarction

6. Subjects with hemodynamic or electrical instability (including shock)

7. Subjects diagnosed with severe, non-catheter-related coronary artery spasm

8. Subjects who are or may be pregnant

9. Subjects with known allergies to contrast media

10. Subjects with renal failure as defined by eGFR < 60.

11. History of TIA or stroke < 6 months

12. History of hemorrhagic stroke

13. Hepatic insufficiency defined as liver cirrhosis, AST/ALT/Alkaline Phosphatase greater than 3 times the upper limit of normal or hyperbilirubinemia.

Lesion Specific Exclusion Criteria These exclusion criteria apply to the target lesion to be imaged by OCT.

1. Lesion located in the left main coronary artery

2. Lesions that are heavily calcified

3. Lesions where OCT cannot be performed due to technical difficulties

4. Other lesions that the investigator deems inappropriate for the procedure such as sites with excessive tortuosity or low flow by TIMI grade.

5. Lesion in saphenous vein or arterial conduit

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Ticagrelor
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
• Clopidogrel
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.

Device:
• Optical Coherence Tomography
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PCI- related myocardial infarction (MI)	PCI related myocardial infarction is defined by the third Universal defintion of myocardial infarction.	PCI-related MI will be assessed within 24 hours after the end of the coronary artery stenting procedure.	No
Primary	Total thrombus burden as measured by the volume of in-stent thrombus quantified by planimetry.	The total thrombus burden measured on OCT images will be assessed. The volume of in-stent thrombus will be quantified by planimetry.	Thrombus burden will be measured at the end of the coronary artery stenting procedure.	No
Secondary	PRI (platelet reactivity index) as measured by the PLT-VASP assay.	The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.	PRI will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure).	No
Secondary	P2Y12 Reaction Units as measured by the VerifyNow P2Y12 assay.	The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.	P2Y12 will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure).	No