NCT01962428

Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI

Randomized Trial of Different Loading Dose of Ticagrelor for Antiplatelet Effect in Patients With Non -ST-segment Elevation ACS Undergoing Percutaneous Coronary Intervention

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: General Hospital of Chinese Armed Police Forces · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus conventional loading dose(180mg) will result in a higher inhibition of platelet aggregation(IPA) without increasing the bleeding events.

Detailed description

After providing written informed consent, all patients will be randomized to receive ticagrelor 360mg or 180mg loading dose(LD),then 90mg bid maintenance dose starting 12 hours after LD.PCI will performed in 2h-72h after they are given the loading dose.All patients should receive acetylsalicylic acid (ASA) 75 to 100 mg daily unless intolerant.IPA at 0, 0.5, 1, 2, 8, 24h after the loading dose of ticagrelor will be measured. CK-MB, troponin I, myoglobin, CRP will be detected at 0h, before PCI, 8h after PCI, 24h after PCI. ECG will be conducted at 0h and within 24h after PCI. Patients returned 28 days for follow-up visits after the loading dose of ticagrelor, documented any adverse events.

Conditions

• Non ST Segment Elevation Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	ticagrelor	Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-10-14
• Last updated: 2016-11-09
• Results posted: 2016-11-09

Locations

2 sites across 1 country: China