Ticagrelor vs. Prasugrel Effects on Infarct Size

• Status: Withdrawn
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study has been designed as a randomized, double-blind trial to provide definitive evidence on the effects of ticagrelor and prasugrel on myocardial salvage in patients with anterior ST Segment Elevation Myocardial Infarction (STEMI) undergoing primary Percutaneous Coronary Intervention (PCI). This study will also measure the effects of ticagrelor vs. prasugrel on secondary endpoints listed above. This study design aims to test the hypothesis that ticagrelor will reduce myocardial infarct size as a proportion of the ischemic area at risk when compared to prasugrel.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yochai Birnbaum
• Collaborator: AstraZeneca
• Treatments: Prasugrel Hydrochloride; Ticagrelor

Criteria

Inclusion Criteria:

1. Informed consent: Signed informed consent prior to any study specific procedures

2. Age: Male and females aged 18 years and older

3. Onset: Presenting to emergency room or cardiac catheterization laboratory within 6 hours of onset of myocardial infarction symptoms

4. Continuing to have ongoing myocardial infarction symptoms

5. EKG findings: ST elevation on ECG with positive T waves in the precordial leads, suggestive of anterior STEMI

6. Triaged for emergency cardiac catheterization (primary PCI protocol)

7. Agree to use an effective contraceptive method beginning at the signing of the informed consent and for at least 30 days after the last dose of study drug. The definition of an effective method of contraception will be based on the judgment of the investigator.

Exclusion Criteria:

1. Prior myocardial infarction

2. Contraindication to ticagrelor and/or prasugrel

3. Contraindication to gadolinium

4. Contraindication to aspirin

5. Treatment with fibrinolytic therapy for the index STEMI

6. High risk of bleeding

7. Presenting with cardiogenic shock

8. Infarction due to stent thrombosis

9. History of a previous coronary artery bypass graft (CABG)

10. Known renal insufficiency (acute kidney injury or Glomerular Filtration Rate < 40 mL/min/1.73 m2).

11. Moderate or severe hepatic impairment

12. Inability to undergo cardiac MRI

13. Indication for aspirin >162 mg/d

14. Indication for Nonsteroidal Anti-Inflammatory Drugs or COX2 inhibitors

15. Pregnant

16. Breast feeding

17. History of intracranial hemorrhage