CompletedNot Applicable

Effects of RF on Clopidogrel Resistance in Patients at High Cardiovascular Risk

Tunisia98 participantsStarted 2010-06

Plain-language summary

Ramadan fasting (RF) has been shown to be associated with vascular and metabolic disorders including glycemic control and lipid profile. It may also alter pharmacologic properties of some medications. Many patients with coronary artery disease (CAD) and under Clopidogrel insist to observe the fasting and taking the risk of altering the pharmacologic proprieties of this drug. The aim of this study is to assess the effects of RF on clopidogrel resistance in patients at high cardiovascular risk with particular interest to patients with Diabetes Mellitus (DM).

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in platelet reactivity between the three time points

Timeframe: 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)

Trial details

NCT IDNCT02624583

SponsorUniversity of Monastir

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-08

View on ClinicalTrials.gov More Coronary Artery Disease trials