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Completed

NCT Number: NCT00930670

Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects

There is conflicting evidence in the literature suggesting that the use of proton pump inhibitors (PPIs), and/or some statins can interfere with clopidogrel antiplatelet effect and result in adverse cardiovascular outcomes in patients treated with coronary artery stents and dual antiplatelet therapy.

The primary aim of the study is to determine the effect of various currently used PPI on platelet aggregation in patients undergoing percutaneous coronary intervention (PCI) and treated with dual antiplatelet therapy.

The secondary aim of the study is to evaluate how statins and 2C19*2 polymorphism modulate the effect of PPI on clopidogrel efficacy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Quebec, G1V4G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must be 18 years of age or older
  • Bare metal stent implantation
  • Discharged with dual antiplatelet therapy for at least 60 days
  • Written informed consent

Exclusion criteria

  • Patients who do not consent to participate in the study
  • Premenopausal women not using contraceptive methods or without a negative pregnancy test in the past week
  • Patients treated or planned to be treated with oral anticoagulants
  • Present treatment with or clear indication for treatment with a PPI or H2 antagonists
  • Allergy or intolerance to study medications including ranitidine, Proton pump inhibitors, atorvastatin, rosuvastatin, aspirin and/or clopidogrel
  • Patient treated with a strong CYP2C19 interacting drug
  • History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before enrollment
  • History of intracranial hemorrhage or intracranial surgery in the last 3 months
  • History of gastro-intestinal ulcers in the last 3 months
  • Any serious illness or any condition that the investigator feels would influence the impact of this therapy on the subject
  • Known platelet count < 100000/mm3 at time of enrollment or within 24 hours prior to enrollment

Treatment and study plan

Rosuvastatin-omeprazole

Drug

Rosuvastatin 20 mg for 1 month. Then rosuvastatin 20mg and omeprazole 20mg for 11 months

Rosuvastatin-pantoprazole

Drug

Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and pantoprazole 40 mg for 11 months

Rosuvastatin-esomeprazole

Drug

Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and esomeprazole 40 mg for 11 months

Rosuvastatin-ranitidine

Drug

Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and ranitidine 300mg for 11 months

Atorvastatin-omeprazole

Drug

Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and omeprazole 20 mg for 11 months

Atorvastatin-pantoprazole

Drug

Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and pantoprazole 40 mg for 11 months

Atorvastatin-esomeprazole

Drug

Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and esomeprazole 40 mg for 11 months

Atorvastatin-ranitidine

Drug

Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and ranitidine 300mg for 11 months

Primary outcomes

  1. Percent change in residual platelet aggregation by light transmittance aggregometry and percent change in platelet reactivity index by VASP

    Time frame: At 30 and 60 days

Secondary outcomes

  1. Resistance to clopidogrel by light transmittance aggregometry (defined by RPA >55%), resistance to clopidogrel by vasodilator-stimulated phosphoprotein (VASP) (defined by PRI >55%)

    Time frame: 30 and 60 days

  2. Prevalence and role of CYP 2C19*2 polymorphism on the effect of PPIs and statins on the antiplatelet activity of clopidogrel

    Time frame: 30 and 60 days

  3. The composite of death from all causes, myocardial infarction, ischemia-driven repeat revascularization, and stroke

    Time frame: 30 days, 60 days and 1 year

  4. Need to stop any antiplatelet medication for gastrointestinal bleeding or peptic ulcer disease

    Time frame: 30 days, 60 days and one year

Sponsors and collaborators

Lead sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Other

Registry information

Acronym: SPICE

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 30, 2009
Registry last updated
Feb 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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