NCT04116931

Brief Summary

This is a prospective, randomized, open-label clinical trial which will enroll 80 acute coronary syndrome (ACS) patients after Percutaneous Transluminal Coronary Intervention (PCI) in China. Patients on maintenance dosing (MD) of aspirin (100 mg/d) and ticagrelor (90 mg twice daily) will be divided into two groups switching from ongoing ticagrelor to clopidogrel 600 mg loading dose (LD)/ 75 mg MD according to their bleeding risk. Then each group will randomly switch at different times(24 hours/ 12 hours after the last MD of ticagrelor). Pharmacodynamic assessments are performed at baseline, and at 4h, 8h, 24h, 48h, 72h hours with platelet aggregation rate by Light Transmittance Aggregometry method (LTA). All patients are followed-up for 30 days.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

September 26, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

June 22, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

September 26, 2019

Last Update Submit

August 21, 2020

Conditions

Acute Coronary Syndrome (ACS)

Keywords

Dual antiplatelet therapy (DAPT)Platelet functionClopidogrelTicagrelorSwitch

Outcome Measures

Primary Outcomes (1)

  • Change of platelet aggregation between different time points

    Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).

    baseline,4 hours,8 hours,24 hours,48 hours,72 hours

Secondary Outcomes (1)

  • Rate of clinical endpoint event

    30 days

Study Arms (4)

clopidogrel-600 mg-12h

EXPERIMENTAL

clopidogrel 600 mg loading dose (LD) 12 hours after the last maintenance dose（MD） of ticagrelor followed by 75 mg MD daily

Drug: Switch ticagrelor to clopidogrel

clopidogrel-600 mg-24h

EXPERIMENTAL

clopidogrel 600 mg loading dose (LD) 24 hours after the last maintenance dose（MD） of ticagrelor followed by 75 mg MD daily

Drug: Switch ticagrelor to clopidogrel

clopidogrel-75 mg-12h

EXPERIMENTAL

clopidogrel 75 mg maintenance dose(MD) 12 hours after the last MD of ticagrelor

Drug: Switch ticagrelor to clopidogrel

clopidogrel-75 mg-24h

EXPERIMENTAL

clopidogrel 75 mg maintenance dose（MD) 24 hours after the last MD of ticagrelor

Drug: Switch ticagrelor to clopidogrel

Interventions

Switch ticagrelor to clopidogrelDRUG

Switch ticagrelor to clopidogrel with 600 mg loading dose (LD)/75 mg maintenance dose（MD）12/24 hours after the last MD of ticagrelor

Also known as: switch
clopidogrel-600 mg-12hclopidogrel-600 mg-24hclopidogrel-75 mg-12hclopidogrel-75 mg-24h

Eligibility Criteria

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

You may qualify if:

  • ≥ 18 years.
  • ACS patients.
  • Patients who are treated with ticagrelor and do not tolerate it.
  • Volunteer to participate and sign informed consent.
  • Approved by national regulatory authorities ethics committees.

You may not qualify if:

  • Patients who are contraindicated, intolerant or resistant to clopidogrel.
  • History of hematological disease or bleeding tendency; platelet count \< 100 × 10\^9 cells/L, or \> 600 × 10\^9 cells/L, hemoglobin \< 100 g/L.
  • Abnormal liver or kidney function (ALT \> 3 ULN; estimated CrCl \< 30 ml/min calculated by Cockcroft-Gault equation); diagnosed severe pulmonary disease.
  • Patients in need of drugs which affect the efficacy of clopidogrel such as miconazole, ketoconazole, andfluconazole.
  • Malignancies or other comorbid conditions with life expectancy less than 1 year.
  • Pregnant or lactating woman.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Chunjian Li, Dr, PhD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunjian Li, Dr, PhD

CONTACT

+86-13701465229drcjli@hotmail.com

Qian Gu

CONTACT

+86-18351972592Solsticeg@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr., MD, Ph.D, Director of CCU Ward

Study Record Dates

First Submitted

September 26, 2019

First Posted

October 7, 2019

Study Start

June 22, 2020

Primary Completion

May 30, 2021

Study Completion

June 30, 2021

Last Updated

August 25, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)