Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212017
Status:
TERMINATED
Last Update Posted:
2018-08-22
First Post:
2005-09-13
Brief Title:
Assessment of an Alpha-glucosidase Inhibitor to Block Cardiac Events in Patients With MI and IGT
Sponsor:
National Cerebral and Cardiovascular Center Japan
Organization:
National Cerebral and Cardiovascular Center Japan
Study Overview
Official Title:
The Japan Working Group for the Assessment That the Alpha-glucosidase Inhibitor Blocks Cardiac Events in Patients With Myocardial Infarction and IGT
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We obtained the final results due to the interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMIN_IDC000000090 | None | None | None |