NCT01587651

Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease

A Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease: 2nd Switching Antiplatelet Agents

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 4, multicenter, open-label (blinded Pharmacodynamic PD results), randomized, 3-arm, parallel-design study of subjects with stable Coronary Artery Disease CAD. This study will compare the PD effect of prasugrel 10 mg QD (once-daily) maintenance dose with ticagrelor 90 mg BID (twice daily) maintenance dose in subjects with stable CAD who have previously received ticagrelor loading does (LD) and maintenance dose (MD)..

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Prasugrel Loading Dose	60mg given as six 10mg film coated tablets
DRUG	Prasugrel Maintenance Dose	10mg maintenance dose, given as one 10mg film coated tablet
DRUG	Ticagrelor Maintenance Dose	one 90mg film coated tablet

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-04-30
• Last updated: 2019-01-09
• Results posted: 2014-04-29

Locations

13 sites across 2 countries: United States, United Kingdom