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

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ClinicalTrials.gov Identifier: NCT02624583
Recruitment Status : Unknown
Verified December 2015 by Nouira, University of Monastir.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2015
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
Nouira, University of Monastir

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 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 DM.


Condition or disease
Coronary Artery Disease Diabetes Mellitus

Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects of Ramadan Fasting on Clopidogrel Resistance in Patients at High Cardiovascular Risk. An Observational Study
Study Start Date : June 2010
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 VerifyNow 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).



Secondary Outcome Measures :
  1. 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) ]

    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.


  2. 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) ]

    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.



Biospecimen Retention:   Samples Without DNA
Venous blood samples were collected from the enrolled participants. Blood samples were analyzed for hemoglobin, hematocrit, platelet cell count, Prothrombin time, activated partial thromboplastin time, and clopidogrel effect on P2Y12 receptor by optical turbidimetry (expressed as P2Y12 reaction units (PRU)).


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients were screened in outpatient clinics (cardiology, endocrinology, internal medicine, family medicine) when they presented for scheduled follow-up.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624583


Locations
Tunisia
Fattouma Bourguiba University Hospital
Monastir, Tunisia, 5000
Sponsors and Collaborators
University of Monastir

Responsible Party: Nouira, Professor, University of Monastir
ClinicalTrials.gov Identifier: NCT02624583     History of Changes
Other Study ID Numbers: 08/2015
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Nouira, University of Monastir:
Fasting
Clopidogrel

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs