Back to results

Efficacy and Safety Study of Ticagrelor

Primary Purpose

Acute Coronary Syndrome

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Clopidogrel

Ticagrelor

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring ACS, CR, PCI, Platelet funtion, Ticagrelor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

General Hospital of Chinese People's Armed Police ForcesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

group 1

group 2

group 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

PRI

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)

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

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 .

Full Information

NCT ID

NCT01812330

First Posted

March 14, 2013

Last Updated

June 23, 2015

Sponsor

General Hospital of Chinese Armed Police Forces

1. Study Identification

Unique Protocol Identification Number

NCT01812330

Brief Title

Efficacy and Safety Study of Ticagrelor

Official Title

The Effect of Ticagrelor on Acute Coronary Syndrome Patients With Clopidogrel Resistance Undergoing Percutaneous Coronary Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

General Hospital of Chinese Armed Police Forces

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

ACS, CR, PCI, Platelet funtion, Ticagrelor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group 1

Arm Type

Experimental

Arm Description

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

Arm Title

group 2

Arm Type

Experimental

Arm Description

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

Arm Title

group 3

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Other Intervention Name(s)

Plavix

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Other Intervention Name(s)

Brilique

Intervention Description

90mg Bid

Primary Outcome Measure Information:

Title

PRI

Description

Platelet funtion were tested by flowcytometric vasodilator-stimulated phosphoprotein(VASP) analysis.And a platelet reactivity index (PRI) was calculated.

Time Frame

post operative 1 month

Secondary Outcome Measure Information:

Title

Major adverse cardiac events(MACEs)

Description

Time Frame

follow-up for 1 month

Title

major and minor bleeding

Description

Time Frame

follow-up for 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

huiliang liu, doctor

Phone

86-10-57976531

lhl518@vip.sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

yujie wei, doctor

Phone

86-10-57976707

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

huiliang liu, doctor

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

General Hospital of Chinese People's Armed Police Forces

City

Beijing

ZIP/Postal Code

100039

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

huiliang liu, doctor

Phone

86-10-57976531

lhl518@vip.sina.com

First Name & Middle Initial & Last Name & Degree

yujie wei, doctor

Phone

86-10-57976707

First Name & Middle Initial & Last Name & Degree

yingping xiao, doctor

12. IPD Sharing Statement

Citations:

PubMed Identifier

20194878

Citation

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.

Results Reference

result

PubMed Identifier

19761935

Citation

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.

Results Reference

result

PubMed Identifier

15738352

Citation

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.

Results Reference

result

PubMed Identifier

16260639

Citation

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.

Results Reference

result

PubMed Identifier

19717846

Citation

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.

Results Reference

result

PubMed Identifier

19324253

Citation

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.

Results Reference

result

Learn more about this trial

Efficacy and Safety Study of Ticagrelor

We'll reach out to this number within 24 hrs