UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002939 |
|---|---|
| Receipt number | 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 15:27:16 |
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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
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
k-tsuka@urahp.yokohama-cu.ac.jp
Sponsor or person
Institute
Division of Cardiology, Yokohama City University Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003561
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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