Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Body Mass Index ≥ 27

NCT01509365 | Completed Phase 4 DMC

• 1 other identifier: 03 PID 11
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel in the patient population overweight or obese with a body mass index (BMI) ≥ 27 kg.m-2.

Conditions

Cardiovascular Disease; Overweight

Keywords

cardiovascular disease; maintenance dose; clopidogrel; overweight; antiplatelet agents

Outcome Measures

Primary Outcomes (1)

• Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation

  6 months

Secondary Outcomes (1)

• ADP-induced platelet aggregation assessed by VerifyNow test

  7 days after selection of patients

Study Arms (3)

sensible

NO INTERVENTION

Patients who show adequate response to loading dose of clopidogrel and receive standard 1x75 mg clopidogrel for at least 7 days.

simple dose

ACTIVE COMPARATOR

Patients who show suboptimal response to loading dose of clopidogrel and receive 1x75 mg clopidogrel for 1 month followed by standard 75 mg clopidogrel for 3 months to one year.

Drug: clopidogrel

double dose

EXPERIMENTAL

Patients who show suboptimal response to loading dose of clopidogrel and receive 1x150 mg clopidogrel for 1 month followed by standard 75 mg clopidogrel for 3 months to one year.

Drug: clopidogrel

Interventions

clopidogrel DRUG

2 tablets of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.

double dose

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female,
• Old (e) of more than 20 years
• BMI ≥ 27kg.m-2
• Patients hospitalized for acute coronary syndrome (Whatever the ST segment and troponin dosage)
• Patients with proven coronary candidates for treatment with Clopidogrel (who received a loading dose of 600mg over 2 hours or treated with 75 mg/day or 150mg / day of clopidogrel for longer than 7 days)

You may not qualify if:

• Patients unwilling.
• Patient participating in another study.
• Patients with cardiogenic shock
• Patient on anti GpIIbIIIa or stopped less than 72 hours before the test aggregability
• Patients scheduled for surgery in less than 6 months
• ischemic stroke older than 6 weeks.
• History of hemorrhagic stroke (any time)
• Patients on or candidates for AVK
• Patients with a different anti ADP (ticlopidine, prasugrel)
• Patients with an indication against clopidogrel (side effects, bleeding ...)
• Thrombocytopenia \< 100000/mm3
• anemia (Ht \< 30%)
• Thrombocythaemia (Ht \> 52%)
• Pregnancy

Sponsors & Collaborators

• Les Laboratoires des Médicaments Stériles: lead
• University Hospital Fattouma Bourguiba: collaborator

Study Sites (1)

cardiology department, hospital Fattouma Bourguiba

Monastir, Monastir Governorate, 5000, Tunisia

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Overweight

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Faouzi Maatouk, MD

  hospital Fattouma Bourguiba

  STUDY CHAIR

• Khaldoun Ben Hamda, MD

  Hospital Fattouma Bourguiba

  PRINCIPAL INVESTIGATOR

• Sonia Hamdi, MD

  Hospital Fattouma Bourguiba

  PRINCIPAL INVESTIGATOR

• Mohsen Hassine

  Hospital Fattouma Bourguiba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 13, 2012
• Study Start: December 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 7, 2015

Record last verified: 2014-10

Locations

TU (1)