Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin

NCT01062516 | Completed Phase 4 DMC

• 1 other identifier: HKEC 2007-176 VerifyNow
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndrome; Acute Myocardial Infarction

Keywords

acute coronary syndrome; acute myocardial infarction; percutaneous coronary intervention; aspirin; clopidogrel; esomeprazole; famotidine; platelet function

Outcome Measures

Primary Outcomes (1)

• P2Y12 reaction units

  28 days

Secondary Outcomes (1)

• percent inhibition

  28 days

Study Arms (2)

1

ACTIVE COMPARATOR

oral esomeprazole 20 mg daily

Drug: esomeprazole 20 mg daily

2

ACTIVE COMPARATOR

oral famotidine 40mg daily

Drug: famotidine 40 mg daily

Interventions

esomeprazole 20 mg daily DRUG

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

1

famotidine 40 mg daily DRUG

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

2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruttonjee Hospital: lead

Study Sites (1)

Ruttonjee Hospital

Hong Kong, China

Location

Related Publications (1)

• Tunggal P, Ng FH, Lam KF, Chan FK, Lau YK. Effect of esomeprazole versus famotidine on platelet inhibition by clopidogrel: a double-blind, randomized trial. Am Heart J. 2011 Nov;162(5):870-4. doi: 10.1016/j.ahj.2011.08.007.

  PMID: 22093203 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Esomeprazole; Famotidine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazoles; Azoles

Study Officials

• Fook Hong Ng, MBBS

  Ruttonjee Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 4, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 5, 2010

Record last verified: 2010-10

Locations

CN (1)