Efficacy and Safety Study of Ticagrelor
The Effect of Ticagrelor on Acute Coronary Syndrome Patients With Clopidogrel Resistance Undergoing Percutaneous Coronary Intervention
1 other identifier
interventional
180
1 country
1
Brief Summary
The purpose of this study is to compare the efficacy and safety of ticagrelor with clopidogrel
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2013
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 14, 2013
CompletedFirst Posted
Study publicly available on registry
March 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedJune 24, 2015
March 1, 2015
2.9 years
March 14, 2013
June 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PRI
Platelet funtion were tested by flowcytometric vasodilator-stimulated phosphoprotein(VASP) analysis.And a platelet reactivity index (PRI) was calculated.
post operative 1 month
Secondary Outcomes (2)
Major adverse cardiac events(MACEs)
follow-up for 1 month
major and minor bleeding
follow-up for 1 month
Study Arms (3)
group 1
EXPERIMENTALGroup 1 will be administered with Clopidogrel 75mg daily until the end of the trial
group 2
EXPERIMENTALGroup 2 will be administered with Clopidogrel 150mg daily until the end of trial
group 3
EXPERIMENTALGroup 3 will be administered with Ticagrelor 90mg twice daily until the end of the trial
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of ACS 2.undergoing PCI 3.with clopidogrel resistance
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Hospital of Chinese People's Armed Police Forces
Beijing, 100039, China
Related Publications (6)
Gurbel PA, Bliden KP, Butler K, Antonino MJ, Wei C, Teng R, Rasmussen L, Storey RF, Nielsen T, Eikelboom JW, Sabe-Affaki G, Husted S, Kereiakes DJ, Henderson D, Patel DV, Tantry US. Response to ticagrelor in clopidogrel nonresponders and responders and effect of switching therapies: the RESPOND study. Circulation. 2010 Mar 16;121(10):1188-99. doi: 10.1161/CIRCULATIONAHA.109.919456. Epub 2010 Mar 1.
PMID: 20194878RESULTCuisset T, Frere C, Quilici J, Poyet R, Gaborit B, Bali L, Brissy O, Morange PE, Alessi MC, Bonnet JL. Comparison of omeprazole and pantoprazole influence on a high 150-mg clopidogrel maintenance dose the PACA (Proton Pump Inhibitors And Clopidogrel Association) prospective randomized study. J Am Coll Cardiol. 2009 Sep 22;54(13):1149-53. doi: 10.1016/j.jacc.2009.05.050.
PMID: 19761935RESULTGurbel PA, Bliden KP, Zaman KA, Yoho JA, Hayes KM, Tantry US. Clopidogrel loading with eptifibatide to arrest the reactivity of platelets: results of the Clopidogrel Loading With Eptifibatide to Arrest the Reactivity of Platelets (CLEAR PLATELETS) study. Circulation. 2005 Mar 8;111(9):1153-9. doi: 10.1161/01.CIR.0000157138.02645.11. Epub 2005 Feb 28.
PMID: 15738352RESULTvon Beckerath N, Taubert D, Pogatsa-Murray G, Schomig E, Kastrati A, Schomig A. Absorption, metabolization, and antiplatelet effects of 300-, 600-, and 900-mg loading doses of clopidogrel: results of the ISAR-CHOICE (Intracoronary Stenting and Antithrombotic Regimen: Choose Between 3 High Oral Doses for Immediate Clopidogrel Effect) Trial. Circulation. 2005 Nov 8;112(19):2946-50. doi: 10.1161/CIRCULATIONAHA.105.559088. Epub 2005 Oct 31.
PMID: 16260639RESULTWallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
PMID: 19717846RESULTJeong YH, Lee SW, Choi BR, Kim IS, Seo MK, Kwak CH, Hwang JY, Park SW. Randomized comparison of adjunctive cilostazol versus high maintenance dose clopidogrel in patients with high post-treatment platelet reactivity: results of the ACCEL-RESISTANCE (Adjunctive Cilostazol Versus High Maintenance Dose Clopidogrel in Patients With Clopidogrel Resistance) randomized study. J Am Coll Cardiol. 2009 Mar 31;53(13):1101-9. doi: 10.1016/j.jacc.2008.12.025.
PMID: 19324253RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
huiliang liu, doctor
Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2013
First Posted
March 18, 2013
Study Start
January 1, 2013
Primary Completion
December 1, 2015
Study Completion
July 1, 2016
Last Updated
June 24, 2015
Record last verified: 2015-03