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

NCT ID: NCT01916902

Last Updated: 2014-05-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28

Brief 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.

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Ticagrelor- Delayed Administration

Subjects receive 180 mg of ticagrelor during cardiac catheterization after diagnostic angiography and prior to stenting. OCT is performed prior to and after coronary artery stenting.

Group Type: ACTIVE_COMPARATOR

Ticagrelor- Delayed Administration

Intervention Type: DRUG

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.

Optical Coherence Tomography

Intervention Type: PROCEDURE

Ticagrelor- Immediate Administration

Subjects receive 180 mg of ticagrelor immediately after study enrollment. OCT is performed prior to and after coronary artery stenting.

Group Type: ACTIVE_COMPARATOR

Ticagrelor- Immediate Administration

Intervention Type: DRUG

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.

Optical Coherence Tomography

Intervention Type: PROCEDURE

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Optical Coherence Tomography

Intervention Type: PROCEDURE

Eligibility Criteria

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

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ik-Kyung Jang, MD, PhD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ik-Kyung Jang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2013P001322

Identifier Type: -

Identifier Source: org_study_id