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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000229 |
Receipt No. | R000000294 |
Scientific Title | Evaluating safety and efficacy of low dose monteplase and nicorandil injected before percutaneous coronary intervention on left ventricular wall motion in patients of acute myocardial infarction:a randomized study. |
Date of disclosure of the study information | 2005/09/14 |
Last modified on | 2016/10/13 |
Basic information | ||
Public title | Evaluating safety and efficacy of low dose monteplase and nicorandil injected before percutaneous coronary intervention on left ventricular wall motion in patients of acute myocardial infarction:a randomized study. | |
Acronym | Injection of low dose monteplase and nicorandil before percutaneous coronary intervention in patients of acute myocardial infarction(SALMAN study). | |
Scientific Title | Evaluating safety and efficacy of low dose monteplase and nicorandil injected before percutaneous coronary intervention on left ventricular wall motion in patients of acute myocardial infarction:a randomized study. | |
Scientific Title:Acronym | Injection of low dose monteplase and nicorandil before percutaneous coronary intervention in patients of acute myocardial infarction(SALMAN study). | |
Region |
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Condition | ||
Condition | Acute myocardial infarction | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the efficacy of injection of low dose monteplase and nicorandil before percutaneous coronary intervention on left ventricular wall motion in patient of acute myocardial infarction. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | Left ventricular wall motion,event of heart failure,death and re-infarction,bleeding complication,time to recanalization,angiographical data,serum CPK and CKMB |
Key secondary outcomes | Restenosis of infarcted artery |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -participants are blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | Numbered container method |
Intervention | ||
No. of arms | 4 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Both Monteplase,15000u per kg,and Nicorandil,4mg bolus injection and 96mg per day continuous injection,are injected. | |
Interventions/Control_2 | Monteplase but no Nicorandil are injected | |
Interventions/Control_3 | Nicorandil but no Monteplase are injected | |
Interventions/Control_4 | Neither Monteplase nor Nicorandil are injected | |
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
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Interventions/Control_10 |
Eligibility | ||||
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Gender | Male and Female | |||
Key inclusion criteria | Acute myocardial infarction within 12 hours from onset. | |||
Key exclusion criteria | Severe hepatic or renal dysfunction,anemia,restricted to use Monteplase or Nicorandil and to treat by PCI. | |||
Target sample size | 88 |
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Name of lead principal investigator |
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Organization | Chiba Emergency Medical Center | ||||||
Division name | Division of Cardiology | ||||||
Zip code | |||||||
Address | 3-32-1, Isobe, Mihama-ku, Chiba city, Chiba, Japan | ||||||
TEL | 043-279-2211 | ||||||
rocky12qq@aol.com |
Public contact | |||||||
Name of contact person |
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Organization | Chiba Emergency Medical Center | ||||||
Division name | Division of Cardiology | ||||||
Zip code | |||||||
Address | 3-32-1, Isobe, Mihama-ku, Chiba city, Chiba, Japan | ||||||
TEL | 043-279-2211 | ||||||
Homepage URL | |||||||
rocky12qq@aol.com |
Sponsor | |
Institute | Chiba Emergency Medical Center |
Institute | |
Department |
Funding Source | |
Organization | Chiba Emergency Medical Center |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000294 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |