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

Non ST Segment Elevation Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962428
• Other study ID #: ISSBRIL0214
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2013
• Last updated: December 17, 2015
• Start date: June 2014
• Est. completion date: October 2015

Study information

• Verified date: September 2015
• Source: General Hospital of Chinese Armed Police Forces
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures.

• Male or non-pregnant female; aged from 18 to 80 years old.

• Patients with non-ST-segment elevation acute coronary syndromes who were scheduled to undergoing PCI.

Exclusion Criteria:

• Any contraindication against the use of ticagrelor.

• On treatment with a P2Y12 receptor antagonist in past 30 days.

• Known allergies to aspirin or ticagrelor.

• On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).

• Known blood dyscrasia or bleeding diathesis.

• ST-segment elevation acute myocardial infarction.

• Non-ST segment elevation acute coronary syndrome with high-risk features warranting emergency coronary angiography.

• Left ventricular ejection fraction =30%; renal failure with creatinine 3 mg/dl; history of liver disease; an increased risk of bradycardia, and concomitant therapy with drugs interfering with CYP3A4 metabolism.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Non ST Segment Elevation Acute Coronary Syndrome

Intervention

Drug:
• ticagrelor
Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.

Locations

Country	Name	City	State
China	General Hospital of Chinese People's Armed Police Forces	Beijing	Beijing
China	General Hospital of Chinese People's Armed Police Forces	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Chinese Armed Police Forces

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	platelet reactivity index(PRI) measured by VASP-P	Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI).	2 hours after the loading dose of ticagrelor	Yes
Secondary	platelet reactivity index (PRI) measured by VASP-P		0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor	Yes
Secondary	bleeding events		follow-up for 28 days after the loading dose of ticagrelor	Yes