Effect of Pretreatment With Ticagrelor on Residual Thrombus After PCI in Patients Presenting With ACS in Comparison With Delayed Treatment at the Time of PCI: an OCT Study

Coronary Artery Disease Clinical Trial

Official title:

Effect of Pretreatment With Ticagrelor on Residual Thrombus After Percutaneous Coronary Intervention (PCI) in Patients Presenting With Acute Coronary Syndrome in Comparison With Delayed Treatment at the Time of PCI: an Optical Coherence Tomography Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01916902
• Other study ID #: 2013P001322
• Status: Withdrawn
• Phase: Phase 4
• First received: August 2, 2013
• Last updated: May 23, 2014
• Start date: February 2014

Study information

• Verified date: May 2014
• 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 presenting with probable acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Consented subjects will be randomized to receive ticagrelor started with a loading dose immediately after enrollment versus receiving a loading dose of ticagrelor during cardiac catheterization after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the volume of thrombus within the new stent will be measured and compared between the groups.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

Patient Characteristics:

1. Males and non-pregnant females > or equal to 18 and < or equal to 79 years of age presenting with suspected acute coronary syndrome (unstable angina or NSTEMI)

2. Patients likely to be 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:

Patient Specific 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 eGFR < 60 ml/min/1.73m2.

11. Subjects currently taking oral anticoagulants with an absolute contraindication to discontinuation of anticoagulation.

12. History of TIA or stroke < 6 months.

13. History of hemorrhagic stroke.

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

15. Cardiac catheterization scheduled within 4 hours of randomization or more then 72 hours after randomization.

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

1. Lesions 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. Lesions in saphenous vein grafts or arterial conduits.

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- Delayed Administration
Subjects are randomized to receive ticagrelor immediately after enrollment versus at the time of cardiac catheterization. OCT is performed prior to and after coronary artery stenting.
• Ticagrelor- Immediate Administration
Subjects are randomized to receive ticagrelor immediately after enrollment versus at the time of cardiac catheterization. OCT is performed prior to and after coronary artery stenting.

Procedure:
• Optical Coherence Tomography

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 definition of myocardial infarction.	PCI-related MI will be assesed 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 bu the PLT-VASP assay.	The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.	PRI iwill be measured at the time of OCT image acquisition.	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 acquisition.	No