Effect of Proton Pump Inhibitor on Residual Platelet Reactivity After Clopidogrel in Homogenous Genetic Strata

NCT01512953 | Unknown Phase 4

• 1 other identifier: GEN-2011-1
• Study Type: interventional
• Target: 522
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to prospectively assess whether there is an interaction between genetic status in terms of 2C19 activity and residual platelet reactivity after clopidogrel intake in patients who underwent coronary stenting for elective, urgent or emergent intervention.

Conditions

Coronary Stenting

Keywords

PPI; clopidogrel; 2C19; Lansoprazole

Outcome Measures

Primary Outcomes (2)

• Maximal platelet aggregation at light transmission aggregometry after 20 μmol/l ADP

  IPA expressed as maximal platelet aggregation (MPA) after 20 μmol/l ADP according to genetic stratum defined as follows: \[(Poor metabolizers: 2C19\*2+ and 2C19\*17-); (intermediate metabolizers: wild type patients or its carrying both 2C19\*2 and \*170; (ultra metabolizers: 2c19\*2- and 2C19\*17+).

  30 days

• maximal platelet aggregation after 5 μmol/l ADP in PPI versus no PPI treated patients

  Patients, stratified by genetic stratum, will be randomized to PPI or no PPI. We assume that that will be an interaction in the IPA after 5 μmol/l ADP at 30 days so that PPI will blunt responsiveness to clopidogrel in poor metabolizer patients only but in intermediate or ultra metabolizers.

  30 days

Study Arms (2)

no PPI

NO INTERVENTION

Patients, stratified according to the genetic stratum, will be randomized not to take any PPI on top of clopidogrel

PPI

EXPERIMENTAL

Patients stratified to the genetic stratum will be randomized to take PPI on top of clopidogrel

Drug: Lansoprazole

Interventions

Lansoprazole DRUG

Lansoprazole 30 mg once a day

PPI

Eligibility Criteria

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

You may qualify if:

• Patients will undergo screening before or soon after PCI depending on their clinical presentation as follows:
• STEMI patients will receive upstream treatment with 600 mg clopidogrel before PCI and will undergo screening for 2C19 status within 24 hours after treatment. Randomization will occur immediately thereafter.
• Stable and NSTEACS patients will be treated upstream with 600 mg clopidogrel and will undergo screening either before PCI or soon after (within 6 hours) revascularisation. In both scenarios randomization will occur immediately after the genotype status is known without any additional delay.

You may not qualify if:

• Patients who can not give informed consent or have a life expectancy of \< 1 year
• Ongoing bleeding or bleeding diathesis or increase bleeding risk or history of bleeding in the last 2 months
• Age \> 90
• Previous stroke or TIA or any intracranial pathology
• Major surgery or trauma within the previous six weeks
• Platelet count \< 100.000 per cubic mm or HCT ,33% or Hb \< 11 gm/dL
• Subjects with an allergy or intolerance to prasugrel or to clopidogrel
• Planned elective cardiac or non-cardiac surgery within 1 month.
• Current or planned therapy with coumadin anticoagulation.

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

University Hospital of Ferrara

Ferrara, ER, 44100, Italy

RECRUITING

MeSH Terms

Interventions

Lansoprazole

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Marco Valgimigli, MD, PhD

CONTACT

0532326874; vlgmrc@unife.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 15, 2012
• First Posted: January 20, 2012
• Study Start: January 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2013
• Last Updated: January 20, 2012

Record last verified: 2012-01

Locations

IT (1)