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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01032668
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:
Bursa Postgraduate Hospital

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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Clopidogrel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: high dose clopidogrel Drug: Clopidogrel
high dose clopidogrel continuing after percutaneous coronary intervention




Primary Outcome Measures :
  1. Death, MI, TVR revascularization, stroke (MACCE) within 30 days and 6 moths [ Time Frame: 6 months. ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032668


Locations
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Turkey
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa, Turkey, 16320
Sponsors and Collaborators
Bursa Postgraduate Hospital
Investigators
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Study Director: Hasan ARI, MD Bursa Postgraduate Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi, Cardiology
ClinicalTrials.gov Identifier: NCT01032668    
Other Study ID Numbers: BYİEAH2
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: August 2008
Keywords provided by Bursa Postgraduate Hospital:
percutaneous coronary intervention, clopidogrel resistance, ASA resistance
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs