OPTImal Management of Antithrombotic Agents: OPTIMA-5

Acute Coronary Syndrome (ACS) Clinical Trial

Official title:

A Randomized Controlled Trial on the Switch From Ticagrelor to Clopidogrel in Acute Coronary Syndrome Patients After Percutaneous Coronary Intervention--OPTImal Management of Antithrombotic Agents: OPTIMA-5

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04116931
• Other study ID #: 011
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome (ACS)
• Syndrome

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