NCT03078465

Brief Summary

To determine the safety and efficacy of Ticagrelor versus Clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2017

Typical duration for phase_3 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 20, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

3.9 years

First QC Date

March 7, 2017

Last Update Submit

August 18, 2021

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 12-Month Freedom From MACE

    Major adverse cardiovascular and cerebrovascular events consist of all-cause death, target vessel myocardial infarction, stroke, stent thrombosis.

    12 months

Secondary Outcomes (7)

  • 12-Month Freedom From Mortality

    12 months

  • 12-Month Freedom From Cardiac death

    12 months

  • 12-Month Freedom From MI

    12 months

  • 12-Month Freedom From TLR

    12 months

  • 12-Month Freedom From TVR

    12 months

  • +2 more secondary outcomes

Other Outcomes (2)

  • 12-Month Freedom From BARC type 2 or above bleeding

    12 months

  • 12-Month Freedom From Major or minor bleeding

    12 months

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Administration of ticagrelor 180mg/day for 12 months.

Drug: Ticagrelor

Clopidogrel

ACTIVE COMPARATOR

Administration of clopidogrel 150 mg/day for 12 months

Drug: Clopidogrel

Interventions

TicagrelorDRUG

Daily administration of ticagrelor 180mg for 12 months

Also known as: BRILINTA
Ticagrelor
ClopidogrelDRUG

Daily administration of clopidogrel 150mg for 12 months

Also known as: Plavix, Talcom
Clopidogrel

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who agreed to the experimental plan which was permitted by IRB;
  • Patients planned to take dual antiplatelet therapy for 12 months.

You may not qualify if:

  • Severe hepatic dysfunction defined as serum transaminase \> 3 times normal limit;
  • Renal dysfunction defined as eGFR \< 30ml/min/1.73m\^2;
  • Co-morbidity with an estimated life expectancy of \< 50 % at 12 months;
  • Scheduled surgery in the next 12 months, which resulted protocol changes;
  • Known allergy against study drug or device;
  • Use of glycoprotein IIb/IIIa inhibitor during the perioperative period;
  • Anticoagulation treatment including warfarin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Related Publications (1)

  • Zhang JJ, Gao XF, Ge Z, Tian NL, Liu ZZ, Lin S, Ye F, Chen SL. High platelet reactivity affects the clinical outcomes of patients undergoing percutaneous coronary intervention. BMC Cardiovasc Disord. 2016 Nov 29;16(1):240. doi: 10.1186/s12872-016-0394-0.

    PMID: 27894260BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

TicagrelorClopidogrel

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Shao-Liang Chen, MD

    Nanjing First Hospital, Nanjing Medical University

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 13, 2017

Study Start

June 20, 2017

Primary Completion

May 30, 2021

Study Completion

May 30, 2021

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)