Assessment of an Alpha-glucosidase Inhibitor to Block Cardiac Events in Patients With MI and IGT
NCT ID: NCT00212017
Last Updated: 2018-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3000 participants
INTERVENTIONAL
2005-04-30
2017-08-31
Brief Summary
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Detailed Description
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100 hospitals will participate in the ABC study. Patients with IGT who have a history of prior myocardial infarction are randomly allocated to receive α-Glucosidase Inhibitor (voglibose) or a standard diet and exercise treatment. The number of patients to be recruited is 3000 and this study will continue for at least 2 years. The primary end-points are:
1. cardiovascular mortality and
2. hospitalization for cardiovascular events.
Effects in suppression of new diabetes development will also be evaluated.
We should recognize IGT as an important therapeutic target to decrease the recurrence of cardiovascular events. The ABC study, a large scale multi-center trial in Japan, will provide us with new evidence on how to treat IGT patients with prior myocardial infarction.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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the voglibose group
Participants in the voglibose group were administered a voglibose tablet (0.2 mg) three times daily before meals.
voglibose
the control group
Participants assigned to the control group were treated only with diet and exercise therapy.
diet and exercise therapy
Interventions
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voglibose
diet and exercise therapy
Eligibility Criteria
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Inclusion Criteria
2. History of myocardial infarction
Exclusion Criteria
2. History of coronary artery bypass graft
3. Severe liver and/or kidney dysfunction
4. History of allergic response to drugs
5. Arteriosclerosis obliterans
20 Years
ALL
No
Sponsors
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Ministry of Health, Labor and Welfare (Japan)
UNKNOWN
National Cerebral and Cardiovascular Center, Japan
OTHER
Responsible Party
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Masafumi Kitakaze
Director
Principal Investigators
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Masafumi Kitakaze, MD, PhD
Role: STUDY_CHAIR
National Cerebral and Cardiovascular Center, Japan
Locations
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National Cardiovascular Center
Suita, Osaka, Japan
Countries
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References
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Asakura M, Kim J, Asanuma H, Hamasaki T, Tsukahara K, Higashino Y, Ishikawa T, Nakama Y, Koba S, Maruyama Y, Tsujimoto M, Himeno H, Ohkusa T, Fujino S, Shimizu M, Endo T, Yoda S, Muroya T, Murohara T, Ohte N, Suzuki H, Kohno T, Fukui K, Shiono T, Takase H, Uzui H, Nagai Y, Hashimoto Y, Ikeda S, Mizuno S, Tamita K, Fujita M, Satake K, Kinoshita Y, Nunohiro T, Sakagami S, Higaki J, Morii I, Sawada R, Hiasa Y, Shigemasa T, Nakahama M, Sata M, Doi O, Ueda T, Yamada T, Yamanouchi T, Yamaguchi H, Morita Y, Hayashi H, Kitakaze M; ABC investigators. Does Treatment of Impaired Glucose Tolerance Improve Cardiovascular Outcomes in Patients with Previous Myocardial Infarction? Cardiovasc Drugs Ther. 2017 Aug;31(4):401-411. doi: 10.1007/s10557-017-6740-3.
Other Identifiers
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UMIN_ID:C000000090
Identifier Type: -
Identifier Source: secondary_id
CSSCJ-3
Identifier Type: -
Identifier Source: org_study_id
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