Home » Trials » SLCTR/2024/038
Can a higher dose overcome clopidogrel resistance – a study of 150mg daily, in patients with abnormal platelet function with and without cyp2c19 gene polymorphism
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SLCTR Registration Number
SLCTR/2024/038
Date of Registration
The date of last modification
Nov 22, 2024
Scientific Title of Trial
Can a higher dose overcome clopidogrel resistance – a study of 150mg daily, in patients with abnormal platelet function with and without cyp2c19 gene polymorphism
Public Title of Trial
The effect of a higher dose of clopidogrel in overcoming clopidogrel resistance as measured by platelet aggregometry in ischaemic heart disease patients with and without CYP2C19 gene polymorphisms
Disease or Health Condition(s) Studied
Ischaemic Heart Disease, CYP2C19polymorphisms, clopidogrel resistance
Scientific Acronym
None
Public Acronym
None
Brief title
The effect of a higher dose of clopidogrel in overcoming the resistance to platelet inhibition in IHD patients with and without CYP2C19 polymorphisms
Universal Trial Number
U1111-1307-9267
Any other number(s) assigned to the trial and issuing authority
18/2024 - ERC
What is the research question being addressed?
Can a higher dose of clopidogrel 150mg/daily overcome the resistance to platelet inhibition in patients with and without genetic polymorphism Cyp2c19, and resistance to the standard dose of clopidogrel 75mg/daily?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Outpatient clinic of the Institute of Cardiology, National Hospital of Sri Lanka.
Intervention: Administration of an increased (150mg/daily) dose of clopidogrel for 14 days followed by measuremt of clopidogrel resistance by platelet function testing using Light transmission platelet aggregometry on a peripheral venous blood sample.
Blinding: Not blinded.
Inclusion criteria
Resistance to platelet aggregation on clopidogrel 75 mg/Day. inhibition is defined as: 5 µM ADP: < 50% ADP-induced decrease in the maximum platelet aggregation from the baseline level. 20 µM ADP: < 70% ADP-induced decrease in the maximum platelet aggregation from the baseline level.
Presence or absence of Gene CYP2C19 polymorphism detected using qualitative PCR
Ischemic heart Disease.
Exclusion criteria
The patients who are taking drugs like; cyclooxygenase-1 inhibitors (Ibuprofen, Naproxen, Indomethacin, Ketorolac, ect);Thienopyridines (Prasugreul); Gp IIb/IIIa receptor inhibitors (Abciximab, Tirofiban, Epifibatide);Antiplatelet agents (Ticagrelor, ect) Beta-lactam antibiotics; Cilostazol; Dipyridamole or nutritional supplements like SSRIs, Dextran and Alcohol.
Blood transfusion/donation – within last 3 months.
Patients given 600mg loading dose. – within last 2 weeks.
Primary outcome(s)
|
1.
20 µM ADP: < 70% ADP-induced decrease in the maximum platelet aggregation from the baseline level |
[ 14 days after starting the intervention ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
50 patients
Countries of recruitment
Sri Lanka
Anticipated start date
2024-12-01
Anticipated end date
2024-12-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Regulatory approvals
Status
Approved
Date of Approval
2024-08-24
Approval number
18-2024
Details of Ethics Review Committee
| Name: | Ethics Review committee of Medical research Institute. |
| Institutional Address: | Ethics Review committee of Medical research Institute. Medical Research Institute, Dannister De Silva Mawatha, Colombo 08 |
| Telephone: | 0112693532/33/34 |
| Email: | ethicsmri@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Nishali Ekanayaka
Consultant Pathologist
Medical Research Institute,Colombo 08,Sri Lanka
0777248084
0777228084
ruvan_nishali.ekanayaka@yahoo.com
Primary study sponsor/organization
Medical Research Institute
Medical Research
P.O. Box: No. 527, Dr. Danister De Silva Mawatha (Baseline road), Colombo 08, Sri Lanka.
011 2 693532-34
0112 691495
ruvan_nishali.ekanayaka@yahoo.com
https://www.mri.gov.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
- All individual participant data collected during the trial, after de-identification - What other documents will be available?Study protocol, statistical analysis plan, analytic code - When will the data be available? (start and end dates) Beginning 3 months and ending 5 years following article publication - With who will the data be shared? Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose - For what types of analyses will the data be shared? - To achieve the aims in an approved proposal - By what mechanism will the data be available? Proposals should be directed to the Email: ruvan_nishali.ekanayaka@yahoo.com/ To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years from the time of publication at ((provide link to proposed IPD database)
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
