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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | C000000140 |
Receipt No. | R000000203 |
Scientific Title | Acarbose for Secondary Prevention of Cardiovascular Events in Patients With Coronary Stenting and Abnormal Glucose Tolerance |
Date of disclosure of the study information | 2005/09/13 |
Last modified on | 2009/03/31 |
Basic information | ||
Public title | Acarbose for Secondary Prevention of Cardiovascular Events in Patients With Coronary Stenting and Abnormal Glucose Tolerance | |
Acronym | Acarbose and Secondary Prevention after Coronary Stenting | |
Scientific Title | Acarbose for Secondary Prevention of Cardiovascular Events in Patients With Coronary Stenting and Abnormal Glucose Tolerance | |
Scientific Title:Acronym | Acarbose and Secondary Prevention after Coronary Stenting | |
Region |
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Condition | ||
Condition | Abnormal Glucose Tolerance | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose of this study is to determine whether the intervention to newly diagnosed abnormal glucose tolerance after coronary stenting will improve the long-term clinical outcome. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | Cardiovascular event free survival time |
Key secondary outcomes | 1)Conversion of abnormal glucose tolerance to type 2 diabetes
2)All cause of death 3)Occurrence of every cardiovascular event 4)Occurrence of in-stent restenosis 5)Regression of intimal plus medial complex of the carotid artery 6)Change in fasting, 2-hour blood glucose and insulin level 7)Change in homeostatis model assessment of insulin resistance 8)Change in HbA1c 9)Change in lipid profile 10)Change in high sensitive CRP 11)Change in Body Mass Index and body weight |
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 considered as adjustment factor in dynamic allocation. |
Blocking | |
Concealment | Central registration |
Intervention | |||
No. of arms | 2 | ||
Purpose of intervention | Prevention | ||
Type of intervention |
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Interventions/Control_1 | Acarbose with a standard lifestyle modification for five years | ||
Interventions/Control_2 | A standard lifestyle modification for five years | ||
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Within 8 weeks since implantation of coronary artery stents for stable angina pectoris or acute coronary syndrome.
2)Abnormal Glucose Tolerance according to 75gOGTT. 3)HbA1c is less than 6.5%. 4)Age is between 20 and 75 (at time of consent). 5)Patients who can give informed consent themselves in writing. |
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Key exclusion criteria | 1)Patients with abnormal glucose tolerance caused by other organic disorders such as pancreatitis, hemochromatosis, post pancreatectomy, hyperthyroidism, Cushing syndrome, Prader-Willi syndrome etc.
2)Patients with planned angioplasty. 3)Patients with uncontrollable congestive heart failure. 4)Less than 6 months since last episode of cerebral infarction. 5)Patients who have received medication for diabetes mellitus before. 6)AST(GOT) exceeding 100 IU/L or ALT(GPT) exceeding 100 IU/L. 7)Creatinine exceeding 2mg/dl. 8)Patients with a history of ileus or less than 6 months since celiotomy. 9)Pregnant women or those who plan pregnancy, or are in the lactation period. 10)Habitual drinker (more than 100ml/day of alcohol). 11)Patients with a history of gastrectomy. 12)Patients for whom it is impossible to follow up for 5 years. 13)Any other reason that the clinical supervisors or clinical researchers may have for considering a case unsuitable for the study. |
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Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kobe City General Hospital | ||||||
Division name | Division of Cardiology | ||||||
Zip code | |||||||
Address | 4-6,Minatojima Nakamachi Chuoku, Kobe, Japan | ||||||
TEL | 078-302-4321 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Institute of Biomedical Research and Innovation | ||||||
Division name | Department of Clinical Research Promotion | ||||||
Zip code | |||||||
Address | 2-2, Minatojima Minamimachi Chuoku, Kobe, Japan | ||||||
TEL | 078-304-5200 | ||||||
Homepage URL | |||||||
minako.wk@gmail.com |
Sponsor | |
Institute | Institute of Biomedical Research and Innovation |
Institute | |
Department |
Funding Source | |
Organization | Institute of Biomedical Research and Innovation |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | Translational Research Informatics Center |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | BRI_CAD_04-02 |
Org. issuing International ID_1 | Translational Research Informatics Center |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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 | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
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Management information | |||||||
Registered date |
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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=R000000203 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |