Asian Diabetes Outcomes Prevention Trial
NCT04286399 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2400
Last updated 2021-04-30
Summary
The aim of this study is to identify patients with DM at high risk of CVD using elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (\>125pg/mL), and (2) intensify therapy using renin-angiotensin system (RAS) antagonists, beta-blockers and sodium glucose co-transporter-2 inhibitors (SGLT2i) for primary prevention of cardiovascular events in this high-risk DM population.
Conditions
Interventions
- DRUG
-
Renin-angiotensin-aldosterone system inhibitors
Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.
- DRUG
-
Beta blocker
Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.
- DRUG
-
SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor Product
Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.
Sponsors & Collaborators
-
Singapore General Hospital
collaborator OTHER -
Mackay Memorial Hospital
collaborator OTHER -
National Taiwan University Hospital
collaborator OTHER -
Peking University People's Hospital
collaborator OTHER -
Medanta, The Medicity, India
collaborator OTHER -
Public Health Foundation of India
collaborator OTHER -
Putrajaya Hospital, Malaysia
collaborator UNKNOWN -
Universiti Teknologi Mara
collaborator OTHER -
National Heart Centre Singapore
lead OTHER
Principal Investigators
-
Carolyn Lam Prof · National Heart Centre Singapore
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-01
- Primary Completion
- 2022-06-30
- Completion
- 2034-06-30
Countries
- Singapore
Study Locations
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