- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00212017
Assessment of an Alpha-glucosidase Inhibitor to Block Cardiac Events in Patients With MI and IGT
The Japan Working Group for the Assessment That the Alpha-glucosidase Inhibitor Blocks Cardiac Events in Patients With Myocardial Infarction and IGT
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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:
- cardiovascular mortality and
- 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Osaka
-
Suita, Osaka, Japan, 565-8565
- National Cardiovascular Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Impaired glucose tolerance
- History of myocardial infarction
Exclusion Criteria:
- Type I diabetes
- History of coronary artery bypass graft
- Severe liver and/or kidney dysfunction
- History of allergic response to drugs
- Arteriosclerosis obliterans
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: the voglibose group
Participants in the voglibose group were administered a voglibose tablet (0.2 mg) three times daily before meals.
|
|
Aktiv komparator: the control group
Participants assigned to the control group were treated only with diet and exercise therapy.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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
Tidsramme: May 2005 and June 2012
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
All cause mortality
Tidsramme: May 2005 and June 2012
|
All cause death
|
May 2005 and June 2012
|
Hospitalization due to coronary artery disease
Tidsramme: May 2005 and June 2012
|
Hospitalization due to coronary artery disease
|
May 2005 and June 2012
|
Progression of IGT to diabetes
Tidsramme: May 2005 and June 2012
|
Progression of IGT to diabetes
|
May 2005 and June 2012
|
Development or deterioration of either hypertension or hyperlipidemia
Tidsramme: May 2005 and June 2012
|
Development or deterioration of either hypertension or hyperlipidemia
|
May 2005 and June 2012
|
Deterioration of renal function
Tidsramme: May 2005 and June 2012
|
Deterioration of renal function
|
May 2005 and June 2012
|
Hospitalization due to cerebrovascular disease
Tidsramme: May 2005 and June 2012
|
Hospitalization due to cerebrovascular disease
|
May 2005 and June 2012
|
Hospitalization due to heart failure
Tidsramme: May 2005 and June 2012
|
Hospitalization due to heart failure
|
May 2005 and June 2012
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Iskæmi
- Patologiske processer
- Nekrose
- Myokardieiskæmi
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Karsygdomme
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Genetiske sygdomme, medfødte
- Kulhydratmetabolisme, medfødte fejl
- Metabolisme, medfødte fejl
- Lysosomale opbevaringssygdomme
- Hyperglykæmi
- Hjernesygdomme, metaboliske
- Hjernesygdomme, metaboliske, medfødte
- Lysosomale opbevaringssygdomme, nervesystemet
- Glykogenopbevaringssygdom
- Myokardieinfarkt
- Infarkt
- Glucoseintolerance
- Glykogenopbevaringssygdom type II
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Glycosidhydrolasehæmmere
- Voglibose
Andre undersøgelses-id-numre
- CSSCJ-3
- UMIN_ID:C000000090
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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