Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin

Acute Coronary Syndrome Clinical Trial

Official title:

Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062516
• Other study ID #: HKEC 2007-176 VerifyNow
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2010
• Last updated: October 2, 2010
• Start date: January 2010
• Est. completion date: September 2010

Study information

• Verified date: October 2010
• Source: Ruttonjee Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators examine the influence of esomeprazole versus famotidine on antiplatelet action of clopidogrel associated with aspirin. At least 100 consecutive patients suffering from acute coronary syndrome or undergoing coronary artery stent implantation , who received aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day or 75mg/day for at least 7 consecutive days), are randomised to receive either esomeprazole 20 mg daily vs famotidine 40 mg daily in a double blinded manner. Clopidogrel effect was tested by measuring residual platelet reactivity (RPR) to ADP by VerifyNow P2Y12 assay (Accumetrics Inc, San Diego, Calif). At baseline, whole blood will be obtained for RPR at least 12 h after clopidogrel loading dose or at least 7 days of maintaince dose. Immediately obtaining the baseline blood, patients will be randomized to receive either esomeprazole (20 mg/day) or famotidine 40 mg/day for 28 days. Double blinding will be performed by encapsulation of study drugs. RPR will be measured again at the 28th day.

The investigators will compare the % inhibition and the P2Y12 reaction Units (PRU) at the 28-day treatment period in the 2 groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients suffering from acute coronary syndrome or undergoing coronary artery stent implantation (PCI) , who received aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day), are recruited.

Exclusion Criteria:

• known active peptic ulcer disease or gastrointestinal within 8 wk

• known iron deficiency anemia with Hb < 10 gm/dl

• mechanical ventilation

• active cancer, liver cirrhosis, end-stage renal failure

• life expectancy < 1 yr

• known allergic to aspirin, clopidogrel, famotidine or esomeprazole

• pregnancy, lactation, child-bearing potential in the absence of contraception,

• co-prescription of NSAID, corticosteroid, or warfarin

• non-oral feeding or impaired GI absorption e.g. vomiting

• patient on proton pump inhibitor within 4 weeks

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• esomeprazole 20 mg daily
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for 28 days
• famotidine 40 mg daily
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for 28 days

Locations

Country	Name	City	State
China	Ruttonjee Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Ruttonjee Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P2Y12 reaction units		28 days	No
Secondary	percent inhibition		28 days	No