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

NCT02624583 | Completed

• 1 other identifier: 08/2015
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 2

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).

Conditions

Coronary Artery Disease; Diabetes Mellitus

Keywords

Fasting; Clopidogrel

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  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)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• aged more than 40 years old.
• having at least two cardiovascular risk factors according to Framingham classification.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (2)

Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia

Monastir, 5000, Tunisia

Location

Fattouma Bourguiba University Hospital

Monastir, 5000, Tunisia

Location

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)).

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus; Fasting

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding Behavior; Behavior

Study Officials

• Semir Nouira, Professor

  University of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 8, 2015
• Study Start: June 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 14, 2020

Record last verified: 2020-09

Locations

TU (2)