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

This study has been completed.
Sponsor:
Information provided by:
Bursa Postgraduate Hospital
ClinicalTrials.gov Identifier:
NCT01032668
First received: December 14, 2009
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032668

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

Publications:

Responsible Party: Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi, Cardiology
ClinicalTrials.gov 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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013