NCT02548611

Comparison of Loading Strategies With Antiplatelet Drugs in Patients Undergoing Elective Coronary Intervention

Intensified Loading With Prasugrel Versus Standard Loading With Clopidogrel in Invasive-treated Patients With Biomarker-Negative Angina Pectoris

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 795 (actual)
• Sponsor: LMU Klinikum · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Use of high loading doses of clopidogrel (antiplatelet drug) just before coronary interventions is associated with improved outcomes after coronary stenting. However the onset of platelet inhibition after clopidogrel loading takes 2 to 4 hours and its action if very variable. A way to overcome this limitation is loading with a more potent antiplatelet drug such as prasugrel. Therefore in the current study the investigators want to compare loading with 60 mg prasugrel (potent antiplatelet drug) and loading with clopidogrel (standard drug) in patients undergoing elective coronary intervention.

Detailed description

Patients with stable or clinically unstable (biomarker-negative) angina pectoris who are in need of coronary intervention will be randomly assigned in one of the treatment strategies - 60 mg of prasugrel or 600 mg clopidogrel just prior to percutaneous coronary intervention (PCI). After PCI all patients will receive clopidogrel 75 mg/d as per standard. The patients will be monitored throughout a 30-day time frame and ischemic and bleeding events will be recorded. The study is powered to show the superiority of single-dose 60 mg prasugrel over single-dose 600 mg clopidogrel regarding the ischemic complications at 30-day follow-up.

Conditions

• Angina Pectoris

Interventions

Type	Name	Description
DRUG	Prasugrel	see arm description
DRUG	Clopidogrel	see arm description

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-08-01
• Completion: 2018-11-01
• First posted: 2015-09-14
• Last updated: 2020-07-17

Locations

5 sites across 2 countries: Germany, Hungary