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

March 14, 2013
February 20, 2014
January 2013
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01812330 on ClinicalTrials.gov Archive Site
  • 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 .
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of Ticagrelor
The Effect of Ticagrelor on Acute Coronary Syndrome Patients With Clopidogrel Resistance Undergoing Percutaneous Coronary Intervention

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Acute Coronary Syndrome
  • Drug: Clopidogrel
    Other Name: Plavix
  • Drug: Ticagrelor
    Other Name: Brilique
  • Experimental: group 1
    Group 1 will be administered with Clopidogrel 75mg daily until the end of the trial
    Intervention: Drug: Clopidogrel
  • Experimental: group 2
    Group 2 will be administered with Clopidogrel 150mg daily until the end of trial
    Intervention: Drug: Clopidogrel
  • Experimental: group 3
    Group 3 will be administered with Ticagrelor 90mg twice daily until the end of the trial
    Intervention: Drug: Ticagrelor

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
July 2016
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: huiliang liu, doctor 86-10-57976531 lhl518@vip.sina.com
Contact: yujie wei, doctor 86-10-57976707
China
 
NCT01812330
20130118 CR
Yes
General Hospital of Chinese Armed Police Forces
General Hospital of Chinese Armed Police Forces
Not Provided
Principal Investigator: huiliang liu, doctor Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
General Hospital of Chinese Armed Police Forces
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP