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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN_ID:C000000090 |
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We obtained the final results due to the interim analysis.
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| Name | Class |
|---|---|
| Ministry of Health, Labour and Welfare, Japan | OTHER_GOV |
The purpose of this study is to evaluate whether an alpha-glucosidase inhibitor, a drug for the suppression of postprandial hyperglycemia, could reduce the recurrence of myocardial infarction in patients with impaired glucose tolerance (IGT) and old myocardial infarction.
Type 2 diabetes mellitus is a well-established risk factor for coronary heart disease and atherosclerotic change in the coronary artery develops subclinically in a state of impaired glucose tolerance (IGT). Recently postprandial hyperglycemia as a feature of impaired glucose tolerance is recognized as a significant risk factor for coronary heart disease. So we designed a prospective randomized multi-center trial named Assessment of an α-glucosidase-inhibitor to Block Cardiac Events in Patients With Myocardial Infarction and IGT (ABC study) to evaluate whether an α-Glucosidase Inhibitor, a drug for the suppression of postprandial hyperglycemia, could reduce the recurrence of myocardial infarction in patients with IGT and old myocardial infarction.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the voglibose group | Active Comparator | Participants in the voglibose group were administered a voglibose tablet (0.2 mg) three times daily before meals. |
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| the control group | Active Comparator | Participants assigned to the control group were treated only with diet and exercise therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| voglibose | Drug |
| ||
| diet and exercise therapy |
| Measure | Description | Time Frame |
|---|---|---|
| the time till the first cardiovascular composite endpoint of death from cardiovascular death, and hospitalization due to nonfatal myocardial infarction, nonfatal unstable angina[16], nonfatal stroke, or treatment with coronary revascularisation | the time till the first cardiovascular composite endpoint of death from the time till the first cardiovascular composite endpoint of death from cardiovascular death, and hospitalization due to nonfatal myocardial infarction, nonfatal unstable angina[16], nonfatal stroke, or treatment with coronary revascularisation | May 2005 and June 2012 |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | All cause death | May 2005 and June 2012 |
| Hospitalization due to coronary artery disease | Hospitalization due to coronary artery disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masafumi Kitakaze, MD, PhD | National Cerebral and Cardiovascular Center, Japan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cardiovascular Center | Suita | Osaka | 565-8565 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28779371 | Result | 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. |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C102817 | voglibose |
| D004032 | Diet |
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D012046 | Rehabilitation |
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Prospective, randomised, open, blinded-endpoint study
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This is an open and blinded-endpoint study
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| May 2005 and June 2012 |
| Progression of IGT to diabetes | Progression of IGT to diabetes | May 2005 and June 2012 |
| Development or deterioration of either hypertension or hyperlipidemia | Development or deterioration of either hypertension or hyperlipidemia | May 2005 and June 2012 |
| Deterioration of renal function | Deterioration of renal function | May 2005 and June 2012 |
| Hospitalization due to cerebrovascular disease | Hospitalization due to cerebrovascular disease | May 2005 and June 2012 |
| Hospitalization due to heart failure | Hospitalization due to heart failure | May 2005 and June 2012 |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |