Efficacy and Safety Study of Ticagrelor

NCT ID: NCT01812330

Last Updated: 2015-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-07-31

Brief Summary

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

Detailed Description

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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

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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group 1

Group 1 will be administered with Clopidogrel 75mg daily until the end of the trial

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

After 600mg loading dose, 75mg or 150mg Qd

group 2

Group 2 will be administered with Clopidogrel 150mg daily until the end of trial

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

After 600mg loading dose, 75mg or 150mg Qd

group 3

Group 3 will be administered with Ticagrelor 90mg twice daily until the end of the trial

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

90mg Bid

Interventions

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Clopidogrel

After 600mg loading dose, 75mg or 150mg Qd

Intervention Type DRUG

Ticagrelor

90mg Bid

Intervention Type DRUG

Other Intervention Names

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Plavix Brilique

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Chinese Armed Police Forces

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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huiliang liu, doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology of General Hospital of Chinese People's Armed Police Forces

Locations

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General Hospital of Chinese People's Armed Police Forces

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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huiliang liu, doctor

Role: CONTACT

86-10-57976531

yujie wei, doctor

Role: CONTACT

86-10-57976707

Facility Contacts

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huiliang liu, doctor

Role: primary

86-10-57976531

yujie wei, doctor

Role: backup

86-10-57976707

References

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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.

Reference Type RESULT
PMID: 20194878 (View on PubMed)

Cuisset 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.

Reference Type RESULT
PMID: 19761935 (View on PubMed)

Gurbel 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.

Reference Type RESULT
PMID: 15738352 (View on PubMed)

von 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.

Reference Type RESULT
PMID: 16260639 (View on PubMed)

Wallentin 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.

Reference Type RESULT
PMID: 19717846 (View on PubMed)

Jeong 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.

Reference Type RESULT
PMID: 19324253 (View on PubMed)

Other Identifiers

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20130118 CR

Identifier Type: -

Identifier Source: org_study_id

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