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

NCT01032668 | Completed Phase 3

• 1 other identifier: BYİEAH2
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

percutaneous coronary intervention, clopidogrel resistance, ASA resistance

Outcome Measures

Primary Outcomes (1)

• Death, MI, TVR revascularization, stroke (MACCE) within 30 days and 6 moths

  6 months.

Secondary Outcomes (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.

  6 months

Study Arms (1)

high dose clopidogrel

EXPERIMENTAL

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

high dose clopidogrel continuing after percutaneous coronary intervention

high dose clopidogrel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bursa Postgraduate Hospital: lead

Study Sites (1)

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, 16320, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 19463377 BACKGROUND

• 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.

  PMID: 21239075 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

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

• Hasan ARI, MD

  Bursa Postgraduate Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 15, 2009
• Study Start: September 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 15, 2009

Record last verified: 2008-08

Locations

TU (1)