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

NCT ID: NCT01032668

Last Updated: 2009-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-12-31

Brief Summary

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

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.

Conditions

Coronary Artery Disease

Keywords

percutaneous coronary intervention, clopidogrel resistance, ASA resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

high dose clopidogrel

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: DRUG

high dose clopidogrel continuing after percutaneous coronary intervention

Interventions

Clopidogrel

high dose clopidogrel continuing after percutaneous coronary intervention

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bursa Postgraduate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cardiology

Principal Investigators

Hasan ARI, MD

Role: STUDY_DIRECTOR

Bursa Postgraduate Hospital

Locations

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 19463377 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21239075 (View on PubMed)

Other Identifiers

BYİEAH2

Identifier Type: -

Identifier Source: org_study_id