Ticagrelor and Clopidogrel on Platelet Effects in Chinese... | NCT04001894

Studies
Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease

NCT04001894

Sponsor

First Affiliated Hospital of Harbin Medical University

Status

Completed

Last Update Posted

Jan 11, 2022Actual

Enrollment

50Actual

Phase

Phase 4

Conditions

Platelet Reactivity

Interventions

Ticagrelor 90mg
Clopidogrel 75mg

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2, 2019Actual

Primary Completion Date

Dec 9, 2020Actual

Completion Date

Dec 9, 2020Actual

First Submitted Date

Jun 26, 2019

First Submission Date that Met QC Criteria

Jun 26, 2019

First Posted Date

Jun 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2021

Last Update Posted Date

Jan 11, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yue LI, Professor, First Affiliated Hospital of Harbin Medical UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital of Harbin Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces thrombotic events in patients with coronary artery disease, but these benefits come at the expense of increased risk of bleeding when compared with aspirin monotherapy. Increased evidence showed that P2Y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with DAPT. Therefore, the investigators performed this study to observe the efficacy of ticagrelor in comparison to clopidogrel in Chinese patients with stable CAD.

Detailed Description

Ticagrelor is a novel, direct-acting, reversibly binding P2Y12 receptor antagonist. When related with clopidogrel, ticagrelor exhibits a more potent and more predictable antiplatelet effect with a faster onset and offset of action. Current guidelines give a recommendation on the use of dual antiplatelet therapy support ticagrelor 90 mg twice daily over clopidogrel 75 mg daily in addition to aspirin in CAD patients. However, increasing evidence showed ticagrelor increased the risk of bleeding. Recent studies showed that P2Y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with DAPT. So the investigators performed this randomized, single-blind, crossover clinical trial to observe the effects of standard-dose ticagrelor and standard-dose clopidogrel on platelet reactivity in Chinese patients with stable CAD.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ticagrelor	Experimental	To observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease	Drug: Ticagrelor 90mg Drug: Clopidogrel 75mg
Clopidogrel	Active Comparator	To observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease	Drug: Ticagrelor 90mg Drug: Clopidogrel 75mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ticagrelor 90mg	Drug	Ticagrelor (90.0 mg twice daily) for 2 weeks, followed by a 2-week washout period then 2 weeks crossover phase of clopidogrel (75mg once daily).	Clopidogrel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The platelet inhibition ratio	Thromboelastogram was used to measure platelet inhibition ratio.	up to 3 months

Secondary Outcomes

Measure	Description	Time Frame
The platelet aggregation ratio.	Light transmittance aggregometry method was used to measure platelet aggregation ratio.	up to 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:•

Aged ≥18 years
Subjects had documented with stable CAD
Women were required to be postmenopausal or surgically sterile
Patients were required to discontinue clopidogrel or ticagrelor at least 14 days before randomization
Patients were required to discontinue aspirin at least 14 days before randomization.

Exclusion Criteria:

Acute coronary syndrome
Planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists other than the study medication, or anticoagulant therapy during the study period
Platelet count <10×10^4/μL
Hstory of bleeding tendency
Diagnosed as respiratory or circulatory instability
Allergy to ticagrelor or clopidogrel

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yue Li, Doctor	First Affiliated Hospital of Harbin Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thrombelastogram		Harbin	Heilongjiang	150001	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077486	Ticagrelor
D000077144	Clopidogrel

Ancestor Terms

ID	Term
D000241	Adenosine
D011684	Purine Nucleosides
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided