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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002939
Receipt No. R000003561
Scientific Title Influence of omeprazole and famotidine on the antiplatelet effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes: A multicenter, randomized prospective study.
Date of disclosure of the study information 2010/01/04
Last modified on 2013/04/02

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Basic information
Public title Influence of omeprazole and famotidine on the antiplatelet effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes: A multicenter, randomized prospective study.
Acronym Prospective study of omeprazole versus famotidine in patients with acute coronary syndromes
Scientific Title Influence of omeprazole and famotidine on the antiplatelet effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes: A multicenter, randomized prospective study.
Scientific Title:Acronym Prospective study of omeprazole versus famotidine in patients with acute coronary syndromes
Region
Japan

Condition
Condition Acute Coronary Syndromes
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the impact of omeprazole and famotidine on the antiplatelet effects of clopidogrel associated with aspirin in patients with acute coronary syndromes
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) Incidence of antiplatelet drugs resistance at 14-28 day treatment period in the 2 groups. Antiplatelet drugs resistance is defined as platelet reactivity index (PRI)>=50% assessed by VASP phosphoprotein analysis.
Key secondary outcomes 1) Incidence of antiplatelet drugs resistance at 14-28 day treatment period in the 2 groups. Antiplatelet drugs resistance is defined as P2Y12 reaction unit (PRU) >=235 assessed by VerifyNow P2Y12 assay.
2) Frequency of 1-year adverse cardiac and cerebrovascular events (including cardiovascular death, myocardial infarction, stent thrombosis, target vessel revascularization, non-target vessel revascularization, and ischemic stroke).
Myocardial infarction is defined as universal definition in 2007, stent thrombosis is defined as ARC definition(definite, probable, possible), and major bleeding is defined as REPLACE-2 criteria.
3) Frequency of 30-day symptom of upper gastrointestinal damage such as epigastric pain, heartburn, nausea, vomiting, hematemesis, or bloody stool (tarry stool)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After baseline assessment of platelet function, patients were randomly assigned by computer-generated randomization sequence to receive omeprazole 10mg once daily for at least 4 weeks. All patients also take aspirin 100mg per day and clopidogrel 75mg per day for at least 4 weeks. Between 14 and 28 days after enrollment, the final platelet function is measured.
Interventions/Control_2 After baseline assessment of platelet function, patients were randomly assigned by computer-generated randomization sequence to receive famotidine 20mg once daily for at least 4 weeks. All patients also take aspirin 100mg per day and clopidogrel 75mg per day for at least 4 weeks. Between 14 and 28 days after enrollment, the final platelet function is measured.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with acute coronary syndromes who are scheduled to undergo coronary stent implantation treated with aspirin and clopidogrel are enrolled.
Key exclusion criteria 1) use of proton-pump inhibitors, H2-receptor antagonists, warfarin, ticlopidine, cilostazole, glycoprotein IIb/IIIa inhibitor, or fibrinolytics within 7 days before enrollment or duing study period.
2) serum hemoglobin level <10 g/dl or >18 g/dl
3) platelet count <100,000 /mm3 or >500,000 /mm3
4) hematologic or malignant disordor
5) past history of recent gastric or duodenal ulcer
6) major bleeding events within 7 days before enrollment
7) severe chronic renal failure (serum creatinine > 2mg/dl)
8) severe liver dysfunction (hepatic cirrhosis or portal hypertension)
9) acute coronary syndromes caused by stent thrombosis or in-stent restenosis
10) drug allergy of study drugs, aspirin or clopidogrel
11) participating in the other trial (phase 1-3)
12) women of pregnant, childbearing potential or lactation
13) patients who are not allowed to participate in the trial by judgement of the treating physician
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kengo Tsukahara
Organization Yokohama City University Medical Center
Division name Division of Cardiology
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kengo Tsukahara
Organization Yokohama City University Medical Center
Division name Division of Cardiology
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email k-tsuka@urahp.yokohama-cu.ac.jp

Sponsor
Institute Division of Cardiology, Yokohama City University Medical Center
Institute
Department

Funding Source
Organization Daiichi Sankyo Co.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 横浜市立大学附属市民総合医療センター(神奈川県)
神奈川県立循環器呼吸器病センター(神奈川県)
済生会横浜市南部病院(神奈川県)
藤沢市民病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2011 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Circulation Journal, Vol.76, No.11, Nov 2012, Page:2673-2680

Management information
Registered date
2009 Year 12 Month 25 Day
Last modified on
2013 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003561

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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