Efficacy and Safety Study of Ticagrelor

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by General Hospital of Chinese Armed Police Forces
Sponsor:
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:
NCT01812330
First received: March 14, 2013
Last updated: February 20, 2014
Last verified: March 2013
  Purpose

The purpose of this study is to compare the efficacy and safety of ticagrelor with clopidogrel


Condition Intervention Phase
Acute Coronary Syndrome
Drug: Clopidogrel
Drug: Ticagrelor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Ticagrelor on Acute Coronary Syndrome Patients With Clopidogrel Resistance 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:
  • PRI [ Time Frame: post operative 1 month ] [ Designated as safety issue: Yes ]
    Platelet funtion were tested by flowcytometric vasodilator-stimulated phosphoprotein(VASP) analysis.And a platelet reactivity index (PRI) was calculated.


Secondary Outcome Measures:
  • Major adverse cardiac events(MACEs) [ Time Frame: follow-up for 1 month ] [ Designated as safety issue: Yes ]
    cardiovascular death,angiographically confirmed stent thrombosis, recurrent acute coronary syndrome defined by the American College of Cardiology/American Heart Association guidelines,and recurrent revascularization by either coronary angioplasty or bypass surgery

  • major and minor bleeding [ Time Frame: follow-up for 1 month ] [ Designated as safety issue: Yes ]
    Major bleeding was defined as intracranial bleeding or clinically-overt bleeding associated with a decrease in hemoglobin of 50 g/L, according to the Thrombolysis inMyocardial Infarction (TIMI) criteria .Minor bleeding was also defined according to TIMI criteria .


Estimated Enrollment: 180
Study Start Date: January 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 1
Group 1 will be administered with Clopidogrel 75mg daily until the end of the trial
Drug: Clopidogrel
Other Name: Plavix
Experimental: group 2
Group 2 will be administered with Clopidogrel 150mg daily until the end of trial
Drug: Clopidogrel
Other Name: Plavix
Experimental: group 3
Group 3 will be administered with Ticagrelor 90mg twice daily until the end of the trial
Drug: Ticagrelor
Other Name: Brilique

Detailed Description:

180 elective percutaneous coronary intervention patients with clopidogrel resistance were randomized to three groups, Group 1:received clopidogrel 75mg qd ;Group 2:received clopidogrel 150mg qd ; Group 3:received ticagrelor 90mg bid after PCI.Platelet funtion were tested by flowcytometric vasodilator-stimulated phosphoprotein(VASP) analysis before PCI,and 3days,7days and 1 month after PCI,respectively.The aim of our study is to compare the efficacy and safety of ticagrelor with clopidogrel

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1.Clinical diagnosis of ACS 2.undergoing PCI 3.with clopidogrel resistance

Exclusion Criteria:

  • 1.any contraindication against the use of clopidogrel and ticagrel 2.Contradiction to aspirin and contrast medium 3.Life expectancy less than 1 year 4.Tumor or inflammatory diseases5. fibrinolytic therapy within 24 hours before randomization 6.a need for oral anticoagulation therapy 7. an increased risk of bradycardia 8.concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer 9.a history of asthma.
  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: NCT01812330

Contacts
Contact: huiliang liu, doctor 86-10-57976531 lhl518@vip.sina.com
Contact: yujie wei, doctor 86-10-57976707

Locations
China
General Hospital of Chinese People's Armed Police Forces Recruiting
Beijing, China, 100039
Contact: huiliang liu, doctor    86-10-57976531    lhl518@vip.sina.com   
Contact: yujie wei, doctor    86-10-57976707      
Principal Investigator: yingping xiao, doctor         
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

Publications:

Responsible Party: General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier: NCT01812330     History of Changes
Other Study ID Numbers: 20130118 CR
Study First Received: March 14, 2013
Last Updated: February 20, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by General Hospital of Chinese Armed Police Forces:
ACS
CR
PCI
Platelet funtion
Ticagrelor

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Clopidogrel
Ticagrelor
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014