Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:
NCT01962428
First received: October 10, 2013
Last updated: September 21, 2016
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Non ST Segment Elevation Acute Coronary Syndrome
Drug: ticagrelor
Phase 4

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

Resource links provided by NLM:


Further study details as provided by General Hospital of Chinese Armed Police Forces:

Primary Outcome Measures:
  • Platelet Reactivity Index(PRI) Measured by VASP-P [ Time Frame: 2 hours after the loading dose of ticagrelor ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Platelet Reactivity Index (PRI) Measured by VASP-P [ Time Frame: 0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor ] [ Designated as safety issue: Yes ]
  • Bleeding Events [ Time Frame: follow-up for 28 days after the loading dose of ticagrelor ] [ Designated as safety issue: Yes ]

Enrollment: 250
Study Start Date: June 2014
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high loading dose of ticagrelor
Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
Drug: ticagrelor
Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
Other Name: Brilinta
Active Comparator: conventional loading dose of ticagrelor
Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
Drug: ticagrelor
Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
Other Name: Brilinta

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01962428

Locations
China, Beijing
General Hospital of Chinese People's Armed Police Forces
Beijing, Beijing, China, 100039
China
General Hospital of Chinese People's Armed Police Forces
Beijing, China
Sponsors and Collaborators
General Hospital of Chinese Armed Police Forces
Investigators
Principal Investigator: Huiliang Liu, Doctor Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
  More Information

Responsible Party: General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier: NCT01962428     History of Changes
Other Study ID Numbers: ISSBRIL0214 
Study First Received: October 10, 2013
Results First Received: September 21, 2016
Last Updated: September 21, 2016
Health Authority: China: Food and Drug Administration

Keywords provided by General Hospital of Chinese Armed Police Forces:
ticagrelor
loading dose
non-ST-segment elevation acute coronary syndromes
percutaneous coronary intervention
the antiplatelet effects
bleeding events
major adverse cardiac events

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 05, 2016