Does Pantoprazole Reduce the Anti-platelet Effect of Clopidogrel?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators sought to evaluate the influence of pantoprazole, indicated as less effective than other proton pump inhibitors, on the antiplatelet effect of clopidogrel, with stratification of the population according to the presence of cytochrome (CYP) 2C19 polymorphism.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Omeprazole and Pantoprazole Antiplatelet Effect of Clopidogrel Clinical Trials(OPEN)

NCT01735227

Acute Coronary Syndromes

UNKNOWN PHASE4

Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Pantoprazole 80 mg in Healthy Subjects

NCT01129427

Healthy

COMPLETED PHASE1

"Pharmacodynamic Comparison of Omeprazole Versus Pantoprazole on Platelet Reactivity in Patients With Acute Coronary Syndromes on Dual Antiplatelet Therapy With New P2Y12 Inhibitors" -Trial dOPPLER-

NCT02028234

Coronary Artery Disease

UNKNOWN PHASE4

Clopidogrel Proton-Pump Inhibitors Study

NCT01016717

Coronary Artery Disease

WITHDRAWN PHASE4

Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel

NCT00405717

Ischemic Heart Disease Acute Coronary Syndromes

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants being treated with a maintenance dose of 75 mg clopidogrel and 100 mg aspirin daily after previous PCI with coronary stenting were included in the study. Participants were randomly assigned to either the pantoprazole 40 mg once-daily group or the ranitidine 150 mg twice-daily group using a computer-generated randomized table. An independent investigator generated the random allocation sequence. Blood samples were collected at 9:00 on day prior to treatment (day 0) and on day 9. Measuring impedance was performed by one independent investigator in a blinded manner.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antiplatelet Effect

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pantoprazole

Drug: Pantoprazole 40 mg once-daily

Group Type ACTIVE_COMPARATOR

Pantoprazole

Intervention Type DRUG

pantoprazole 40 mg once-daily

Ranitidine

Drug: Ranitidine 150 mg twice-daily

Group Type EXPERIMENTAL

Ranitidine

Intervention Type DRUG

ranitidine 150 mg twice-daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pantoprazole

pantoprazole 40 mg once-daily

Intervention Type DRUG

Ranitidine

ranitidine 150 mg twice-daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients being treated with a maintenance dose of 75 mg clopidogrel and 100 mg aspirin daily after previous PCI with coronary stenting were included in the study. All patients received standardized therapy with a loading dose of 600 mg of clopidogrel hydrogen sulfate and 400 mg aspirin.

All participants had a normal platelet count (150,000-450,000/mL).

Exclusion Criteria

* Patients with severe liver disorders, current gastrointestinal disorders, a current infection, congestive heart failure, or a known bleeding disorder as well as patients on bivalirudin or glycoprotein IIb/III antagonists within the last 7 days were excluded from the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No