Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02624583
Status:
COMPLETED
Last Update Posted:
2020-09-14
First Post:
2015-12-03
Brief Title:
Effects of RF on Clopidogrel Resistance in Patients at High Cardiovascular Risk
Sponsor:
University of Monastir
Organization:
University of Monastir
Study Overview
Official Title:
Effects of Ramadan Fasting on Clopidogrel Resistance in Patients at High Cardiovascular Risk An Observational Study
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RFeCloR
Brief 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
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 RamadanPost-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 sunsetthe 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 01 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 35 mmoll Compliance to current treatment clopidogrel oral hypoglycemic agentsstatins 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 am at which all participants were fast For the purpose of the studywe asked our patients to take clopidogrel treatment as late as possible
As Ramadan month during the study period has coincided with summer seasonclopidogrel was generally taken between midnight and1 am We added this detail in the paper
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 01 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 35 mmoll Compliance to current treatment clopidogrel oral hypoglycemic agentsstatins 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 am at which all participants were fast For the purpose of the studywe asked our patients to take clopidogrel treatment as late as possible
As Ramadan month during the study period has coincided with summer seasonclopidogrel was generally taken between midnight and1 am We added this detail in the paper
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None