The EFFect of hIgh Dose ClopIdogrel treatmENT in Patients With Clopidogrel Resistance (EFFICIENT)

Continuing high dose clopidogrel treatment after elective PCI decreased adverse cardiac events in patients with clopidogrel resistance

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Clopidogrel

Detailed Description

Aim:

Primary objective:

• To evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac events after elective PCI in patients with clopidogrel resistance

Secondary objective:

• To evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac events after elective PCI
• To evaluate the effect of continuing high dose clopidogrel treatment on bleeding complications after elective PCI
• To evaluate the clinical effect of VerifyNow which use as a clopidogrel resistance kit.

Study central:

Bursa Postgraduate Hospital, Cardiology Clinic

Study population:

we planned to enrol 180 patients. 50% of patients without clopidogrel resistance (control group: 90 patients) 50% have clopidogrel resistance. Than we randomise the patients (with clopidogrel resistance) in two groups (group 1:45 patients (75mg/day), group 2:45 patients (150mg/day))

inclusion criteria:

• The patients; who have planned elective PCI and have had written informed consent for participation to study.
• Age>18 year-old,
• The native coronary artery;lesion with narrowing >=70%

Exclusion criteria:

• Patients have allergy for ASA, Clopidogrel and heparin
• Patients who performed primary PCI
• Patients with acute coronary syndrome
• Patients with have a history of PCI and use clopidogrel
• Patients on warfarin therapy
• Patients who have bleeding diathesis, or have high risk for bleeding.

Study works:

• Write case report form for all patients
• Control for inclusion criteria.
• Evaluate the clopidogrel and ASA resistance with VerifyNow kit. Than randomised the patients.
• Demographic data (age, gender)
• Height, weight, BMI and GFR
• Risk factors
• laboratory data (biochemical and hematologic)
• Medication history
• Echocardiographic data
• Angiographic data
• PCI data(vessel diameter, stent diameter, lesion and stent length, performed PTCA or not, etc)

• Note complication (MACE, bleeding, hematoma etc)

  4 weeks later note the first control data and re assess the clopidogrel resistance with VerifyNow kit in patients groups 1 and 2.

Six months later note the second control data.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 3

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16320
    • Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patients; who have planned elective PCI and have had written informed consent for participation to study.
• Age>18 year-old,
• The native coronary artery;lesion with narrowing >=70%

Exclusion Criteria:

• Patients have allergy for ASA, Clopidogrel and heparin
• Patients who performed primary PCI
• Patients with acute coronary syndrome
• Patients with have a history of PCI and use clopidogrel
• Patients on warfarin therapy
• Patients who have bleeding diathesis, or have high risk for bleeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high dose clopidogrel	Drug: Clopidogrel; high dose clopidogrel continuing after percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Death, MI, TVR revascularization, stroke (MACCE) within 30 days and 6 moths	6 months.

Secondary Outcome Measures

Outcome Measure	Time Frame
Major or minor bleeding according to TIMI criteria 30 days and 6 months To evaluate the clinical effect of VerifyNow which use as a clopidogrel resistance kit 30 days and 6 months.	6 months

Collaborators and Investigators

• Sponsor: Bursa Postgraduate Hospital

Publications and helpful links

General Publications

• Aleil B, Jacquemin L, De Poli F, Zaehringer M, Collet JP, Montalescot G, Cazenave JP, Dickele MC, Monassier JP, Gachet C. Clopidogrel 150 mg/day to overcome low responsiveness in patients undergoing elective percutaneous coronary intervention: results from the VASP-02 (Vasodilator-Stimulated Phosphoprotein-02) randomized study. JACC Cardiovasc Interv. 2008 Dec;1(6):631-8. doi: 10.1016/j.jcin.2008.09.004.
• Ari H, Ozkan H, Karacinar A, Ari S, Koca V, Bozat T. The EFFect of hIgh-dose ClopIdogrel treatmENT in patients with clopidogrel resistance (the EFFICIENT trial). Int J Cardiol. 2012 Jun 14;157(3):374-80. doi: 10.1016/j.ijcard.2010.12.083. Epub 2011 Jan 15.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Estimate): December 15, 2009
• Last Update Submitted That Met QC Criteria: December 14, 2009
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention, clopidogrel resistance, ASA resistance
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: BYİEAH2