Asian Diabetes Outcomes Prevention Trial

NCT04286399 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2400

Last updated 2021-04-30

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04286399 on ClinicalTrials.gov