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

Coronary Artery Disease Clinical Trial

— EFFICIENT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032668
• Other study ID #: BYIEAH2
• Status: Completed
• Phase: Phase 3
• First received: December 14, 2009
• Last updated: December 14, 2009
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2008
• Source: Bursa Postgraduate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Clopidogrel
high dose clopidogrel continuing after percutaneous coronary intervention

Locations

Country	Name	City	State
Turkey	Bursa Yüksek Ihtisas Egitim ve Arastirma Hastanesi	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Postgraduate Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death, MI, TVR revascularization, stroke (MACCE) within 30 days and 6 moths		6 months.	Yes
Secondary	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	Yes