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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04116931
Other study ID # 011
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 22, 2020
Est. completion date June 30, 2021

Study information

Verified date August 2020
Source The First Affiliated Hospital with Nanjing Medical University
Contact Chunjian Li, Dr, PhD
Phone +86-13701465229
Email drcjli@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The primary endpoint of the study was platelet inhibition measured by Light Transmittance Aggregometry method(LTA). Secondary clinical endpoints included a 30-day major adverse cardiovascular endpoint (MACE) defined as a composite of cardiovascular death, recurrent myocardial infarction, target vessel revascularisation or stroke and individual components of the MACE. Safety endpoints of 30-day TIMI major and minor bleed were also evaluated.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date June 30, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- = 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.

Exclusion Criteria:

- 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.

Study Design


Intervention

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

Locations

Country Name City State
China First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Rate of clinical endpoint event Secondary clinical endpoints included a 30-day major adverse cardiovascular endpoint (MACE) defined as a composite of cardiovascular death, recurrent myocardial infarction, target vessel revascularisation or stroke and individual components of the MACE. Safety endpoints of 30-day TIMI major and minor bleed were also evaluated. 30 days
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