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

This study has been completed.
Information provided by:
Bursa Postgraduate Hospital Identifier:
First received: December 14, 2009
Last updated: NA
Last verified: August 2008
History: No changes posted
Continuing high dose clopidogrel treatment after elective PCI decreased adverse cardiac events in patients with clopidogrel resistance

Condition Intervention Phase
Coronary Artery Disease
Drug: Clopidogrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Bursa Postgraduate Hospital:

Primary Outcome Measures:
  • Death, MI, TVR revascularization, stroke (MACCE) within 30 days and 6 moths [ Time Frame: 6 months. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 192
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high dose clopidogrel Drug: Clopidogrel
high dose clopidogrel continuing after percutaneous coronary intervention

  Show Detailed Description


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01032668

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa, Turkey, 16320
Sponsors and Collaborators
Bursa Postgraduate Hospital
Study Director: Hasan ARI, MD Bursa Postgraduate Hospital
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi, Cardiology Identifier: NCT01032668     History of Changes
Other Study ID Numbers: BYİEAH2 
Study First Received: December 14, 2009
Last Updated: December 14, 2009
Health Authority: Turkey: Ethics Committee

Keywords provided by Bursa Postgraduate Hospital:
percutaneous coronary intervention, clopidogrel resistance, ASA resistance

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses processed this record on February 11, 2016