NCT02298088

Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis

Phase III, Randomized, International, Multicenter, Open Label, With Blinded Adjudication of Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor Compared With Clopidogrel in Patients With Acute Coronary Syndrome With ST Elevation Treated With Pharmacological Thrombolysis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,799 (actual)
• Sponsor: Hospital do Coracao · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Administration of Ticagrelor in patients with ST elevation myocardial infarction treated with pharmacological thrombolysis

Detailed description

Phase III, Randomized, International, Multicenter, Open label, with Blinded Adjudication of Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor Compared with Clopidogrel in Patients with Acute Coronary Syndrome with ST Elevation Treated with Pharmacological Thrombolysis.

Conditions

• Acute ST Segment Elevation Myocardial Infarction
• Thrombolysis in Myocardial Infarction Flow

Interventions

Type	Name	Description
DRUG	Ticagrelor 180 mg	Ticagrelor, 180 mg as early as possible after the index event and not \>24 h post event followed by 90 mg twice daily for 12 months.
DRUG	Clopidogrel	300 mg clopidogrel as early as possible after the index event and not \> 24h post event, followed by 75mg/day for 12 months. For patients with \> 75 years the recommended load dose is 75 mg instead 300 mg.

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-12-01
• Completion: 2019-01-01
• First posted: 2014-11-21
• Last updated: 2019-02-15

Locations

153 sites across 10 countries: Argentina, Australia, Brazil, Canada, China, Colombia, New Zealand, Peru, Russia, Ukraine