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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02624583 |
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Date of registration:
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03/12/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of RF on Clopidogrel Resistance in Patients at High Cardiovascular Risk
RFeCloR |
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Scientific title:
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Effects of Ramadan Fasting on Clopidogrel Resistance in Patients at High Cardiovascular Risk. An Observational Study |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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98 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02624583 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Tunisia
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Contacts
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Name:
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Semir Nouira, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Monastir |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- aged more than 40 years old.
- having at least two cardiovascular risk factors according to Framingham
classification.
- patients willing to fast ramadan and taking clopidogrel therapy for at least six
months prior to inclusion.
Exclusion Criteria:
- patients under 40 years.
- patients with unstable diabetes.
- repeated hypoglycemic episodes
- patients with severe uncontrolled hypertension (higher arterial blood pressure than
179/109 mmHg despite antihypertensive treatment)
- acute coronary syndrome within the past year prior to enrollment
- current or previous (14 days) use of glycoprotein IIb/IIIa
- severe cardiovascular and cerebrovascular disease
- inability to give informed consent
- baseline platelet count < 100x103/ml
- current use of antidepressants
- serum creatinine levels higher than 1.4 mg/dL for women and 1.5 mg/dL for men
- hepatic function tests at least 2.5 times higher than normal levels
- terminal disease with a <1 year expected mortality
Age minimum:
40 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Coronary Artery Disease
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Primary Outcome(s)
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Changes in platelet reactivity between the three time points
[Time Frame: the last week before Ramadan (Pre-R); the last week of Ramadan (R); and during the last week of the month following Ramadan (Post-R)]
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Secondary Outcome(s)
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Changes in the glycemic profile between the three time points
[Time Frame: the last week before Ramadan (Pre-R); the last week of Ramadan (R); and during the last week of the month following Ramadan (Post-R)]
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Changes in the lipid profile between the three time points
[Time Frame: the last week before Ramadan (Pre-R); the last week of Ramadan (R); and during the last week of the month following Ramadan (Post-R)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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