Coronary Artery DiseaseRFeCloRNCT02624583
Effects of RF on Clopidogrel Resistance in Patients at High Cardiovascular Risk
An observational study of Coronary Artery Disease and Diabetes Mellitus, run by University of Monastir at 2 sites in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus
- How many people
- 98 participants
- Where
- 2 sitesTunisia
- Study dates
- Jun 2010to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were screened in outpatient clinics (cardiology, endocrinology, internal medicine, family medicine) when they presented for scheduled follow-up.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites
Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
Monastir, 5000
Fattouma Bourguiba University Hospital
Monastir, 5000
About this study
Official title: Effects of Ramadan Fasting on Clopidogrel Resistance in Patients at High Cardiovascular Risk. An Observational Study
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).
Read the detailed description
The study involved three separate assessment visits in each year: 1) the last week before Ramadan (Pre-R) which represented the baseline period; 2) the last week of Ramadan (R); 3) and during the last week of the month following Ramadan(Post-R). Each patient served as his own control and was required to take the prescribed clopidogrel dose daily and chart the intake in a dosing diary. The duration of fasting was approximately 12 h from sunrise to sunset(the time of abstinence from food) during a 30 day period. The assessment in each of the three visits involved clinical exam and blood sampling for hematologic and metabolic tests
Body weight and height were performed by a well-trained staff member. Weight was measured while the subjects were minimally clothed without shoes using digital scales and recorded to the nearest 0.1 kg. Body Mass Index (BMI) was calculated as body weight (kg) divided by squared height in meters (m2). Physical examination was carried out in all participants including systolic (SBP), diastolic (DBP) blood pressure, and heart rate. The visit is completed by a questionnaire on diet beginning 2 days before the blood sampling. No special nutritional regimen was applied to the participants during the study. All subjects were encouraged to continue their usual lifestyle and activities.
The rate of hypoglycemic (symptomatic and non-symptomatic) and hyperglycemic episodes requiring emergency department (ED) admission was recorded within the three periods of the study. Hypoglycemia was defined as blood glucose <3.5 mmol/l. Compliance to current treatment (clopidogrel, oral hypoglycemic agents,statins...) was assessed by the attending physician based on interview and pill count. Venous blood samples were collected from the enrolled participants during the three time points. The time of blood sampling in the study was 9-10 a.m., at which all participants were fast. For the purpose of the study,we asked our patients to take clopidogrel treatment as late as possible.
As Ramadan month during the study period has coincided with summer season,clopidogrel was generally taken between midnight and1 am. We added this detail in the paper..
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Keywords
- Fasting, Clopidogrel
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Fasting
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in platelet reactivity between the three time points
the platelet reactivity to clopidogrel is assessed by the 'Verify Now P2Y12' point-of-care assay .
Results are reported as P2Y12 reaction units (PRU); the lower the PRU value, the higher the platelet aggregation inhibition by clopidogrel.
High platelet reactivity after clopidogrel (clopidogrel resistance) was defined at two cutoff values (PRU≥235 and ≥ 208).
Measured: 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)
Secondary outcomes (2)
Changes in the glycemic profile between the three time points
An automated analyzer (Beckman Coulter DXC 600, UK) measured the concentrations of biochemical parameters using the appropriate reagents.
Glucose concentrations are measured by an enzymatic colorimetric method and expressed in mmol/l.
Measured: 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)
Changes in the lipid profile between the three time points
An automated analyzer (Beckman Coulter DXC 600, UK) measured the concentrations of biochemical parameters using the appropriate reagents.
The total cholesterol (TC) and triglycerides (TG) were determined using an enzymatic colorimetric method. High-density lipoprotein cholesterol (HDL-C) concentrations were determined by immuno-inhibition. Low-density lipoprotein cholesterol (LDL-C) was calculated using the Friedewald formula: LDL-C (mmol/L) =TC - HDL-C - TG: 2.2.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startJun 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Semir Nouira, Professor, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624583
- Sponsor's protocol ID
- 08/2015
- Acronym
- RFeCloR
- Status last verified
- Sep 2020
- First submitted
- 3 Dec 2015
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ramadan Fasting on Clopidogrel Resistance in Patients at High Cardiovascular Risk. An Observational Study
- ClinicalTrials.gov ID
- NCT02624583
- Acronym / sponsor ID
- RFeCloR / 08/2015
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Keywords
- Fasting, Clopidogrel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Jun 2010 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study involved three separate assessment visits in each year: 1) the last week before Ramadan (Pre-R) which represented the baseline period; 2) the last week of Ramadan (R); 3) and during the last week of the month following Ramadan(Post-R). Each patient served as his own control and was required to take the prescribed clopidogrel dose daily and chart the intake in a dosing diary. The duration of fasting was approximately 12 h from sunrise to sunset(the time of abstinence from food) during a 30 day period. The assessment in each of the three visits involved clinical exam and blood sampling for hematologic and metabolic tests
Body weight and height were performed by a well-trained staff member. Weight was measured while the subjects were minimally clothed without shoes using digital scales and recorded to the nearest 0.1 kg. Body Mass Index (BMI) was calculated as body weight (kg) divided by squared height in meters (m2). Physical examination was carried out in all participants including systolic (SBP), diastolic (DBP) blood pressure, and heart rate. The visit is completed by a questionnaire on diet beginning 2 days before the blood sampling. No special nutritional regimen was applied to the participants during the study. All subjects were encouraged to continue their usual lifestyle and activities.
The rate of hypoglycemic (symptomatic and non-symptomatic) and hyperglycemic episodes requiring emergency department (ED) admission was recorded within the three periods of the study. Hypoglycemia was defined as blood glucose <3.5 mmol/l. Compliance to current treatment (clopidogrel, oral hypoglycemic agents,statins...) was assessed by the attending physician based on interview and pill count. Venous blood samples were collected from the enrolled participants during the three time points. The time of blood sampling in the study was 9-10 a.m., at which all participants were fast. For the purpose of the study,we asked our patients to take clopidogrel treatment as late as possible.
As Ramadan month during the study period has coincided with summer season,clopidogrel was generally taken between midnight and1 am. We added this detail in the paper..
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were screened in outpatient clinics (cardiology, endocrinology, internal medicine, family medicine) when they presented for scheduled follow-up.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
the platelet reactivity to clopidogrel is assessed by the 'Verify Now P2Y12' point-of-care assay . Results are reported as P2Y12 reaction units (PRU); the lower the PRU value, the higher the platelet aggregation inhibition by clopidogrel. High platelet reactivity after clopidogrel (clopidogrel resistance) was defined at two cutoff values (PRU≥235 and ≥ 208).
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semir Nouira, Professor principal investigator
University of Monastir
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Diabetes Mellitus, run by University of Monastir at 2 sites in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.