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

NCT01735227 | Unknown Phase 4 DMC

• 1 other identifier: NH2012-9-20
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 2

Brief Summary

In order to further clarify the interaction of PPIs with clopidogrel anti - platelet effect , the investigators designed a clinical randomized controlled trials of omeprazole and pantoprazole antiplatelet effect of clopidogrel .In this experiment , the investigators have taken a randomized NSTE-ACS hospitalized patients met the inclusion criteria were randomly divided into omeprazole and pantoprazole groups . On the day of admission , all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg + aspirin 300mg and omeprazole group taking omeprazole 20mg / d , pantoprazole group taking pantoprazole 20mg / d. Respectively, on the day of admission ( before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days , each taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical adverse events ( including death , myocardial infarction , and any revascularization , stent thrombosis , recurrent angina , rehospitalization due to cardiovascular disease , bleeding events) . To assess the impact of PPIs on clopidogrel antiplatelet effect by observing 1 year follow-up results , and further explore the optimal combination of dual anti-platelet and joint PPIs course of treatment , appropriate dosage and the best time to provide reasonable for clinical programs to create a personalized treatment system , improve the patient's quality of life .

Conditions

Acute Coronary Syndromes

Keywords

pantoprazole; omeprazole; anti - platelet effect

Outcome Measures

Primary Outcomes (1)

• Platelet aggregation rate(AA 、ADP)

  30 days

Secondary Outcomes (1)

• clinical adverse events

  12 months

Study Arms (2)

omeprazole group

EXPERIMENTAL

omeprazole group:all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg(1 year) + aspirin 300mg(1 month)+ aspirin 100mg(long-term)and taking omeprazole 20mg/d(1 month).on the day of admission ( before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days , each taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical adverse events ( including death , myocardial infarction , and any revascularization , stent thrombosis , recurrent angina , rehospitalization due to cardiovascular disease , bleeding events) .

Drug: omeprazole; Drug: Pantoprazole

pantoprazole group

EXPERIMENTAL

pantoprazole group: all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg(1 year) + aspirin 300mg(1 month)+ aspirin 100mg(long-term),taking pantoprazole 20mg/d(1 month).

Drug: omeprazole; Drug: Pantoprazole

Interventions

omeprazole DRUG

all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg(1 year) + aspirin 300mg(1 month)+ aspirin 100mg(long-term)and omeprazole group taking omeprazole 20mg/d

omeprazole group; pantoprazole group

Pantoprazole DRUG

On the day of admission , all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg + aspirin 300mg and omeprazole group taking omeprazole 20mg / d , pantoprazole group taking pantoprazole 20mg / d. Respectively, on the day of admission ( before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days , each taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical adverse events ( including death , myocardial infarction , and any revascularization , stent thrombosis , recurrent angina , rehospitalization

omeprazole group; pantoprazole group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ACS (including unstable angina pectoris, non-ST-segment elevation myocardial infarction and ST-elevation myocardial infarction) ;
• The age between18 and 75 ;
• Informed consent.

You may not qualify if:

• Receiving GP IIb / IIIa receptor antagonist treatment;
• Had received prior to enrollment 7d cilostazol;
• Dual antiplatelet therapy contraindications;
• NYHA grade III \~ IV;
• Presence of multivessel severe coronary lesions , need elective coronary revascularization;
• The need for long-term use of warfarin after valve surgery or persistent atrial fibrillation;
• Severe liver or kidney dysfunction;
• Has not been cured of peptic ulcer or presence of bleeding tendency;
• Who complicate the known bleeding tendency and blood system diseases;
• Have a history of intracranial hemorrhage within 6 monhs;
• Planned surgery recently;
• Pregnancy;
• Other serious illness, life expectancy less than 6 months;
• Nearly 1 year underwent PCI , regular take aspirin 、clopidogrel since;

Sponsors & Collaborators

• Yaling Han: lead

Study Sites (2)

OPEN trail

Shenyang, Liaoning, 110016, China

Location

ShenyangNH

Shenyang, Liaoning, 110016, China

Location

Related Publications (1)

• Gu RX, Wang XZ, Li J, Deng J, Li XX, Wang J. Effects of omeprazole or pantoprazole on platelet function in non-ST-segment elevation acute coronary syndrome patients receiving clopidogrel. Mil Med Res. 2016 Dec 15;3:38. doi: 10.1186/s40779-016-0107-0. eCollection 2016.

  PMID: 28018669 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Omeprazole; Pantoprazole

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

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

Study Officials

• Han Yaling, MD

  Shenyang Northern Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Han Yaling, MD

CONTACT

+86-024-28897309; lijing790126@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: vice president

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 28, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 28, 2012

Record last verified: 2012-11

Locations

CN (2)