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Clinical Trials/EUCTR2021-002813-33-IT
EUCTR2021-002813-33-IT
Active, Not Recruiting
Phase 1

Early use of dapaglifozin in diabetic patients with acute myocardial infarction and reduced ejection fraction: the randomized ARMYDA-9 DAPA trial - ARMYDA-9 DAPA trial

AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITà DI NOVARA0 sites140 target enrollmentJanuary 27, 2022
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DrugsFORXIGA - 10 MG - COMPRESSE RIVESTITE CON FILM- USO ORALE - BLISTER CALENDARIZZATO (ALU/ALU) - 28 COMPRESSE

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITà DI NOVARA
Enrollment
140
Status
Active, Not Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 27, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITà DI NOVARA

Eligibility Criteria

Inclusion Criteria

  • •Type 2 diabetes mellitus
  • •ST\-elevate myocardial infarction
  • •Percutaneous coronary angioplasty \<12 hours from symptom onset
  • •TIMI coronary flow 0\-1 at the time of primary PCI
  • •Left ventricle ejection fraction 40% assessed within 12 hours from admission
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 70
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •Cardiogenic shock
  • •Symptomatic hypotension
  • •History of restrictive cardiomyopathy, constrictive pericarditis, or untreated severe heart valve disease
  • •History of diabetic ketoacidosis, secondary diabetes or type 1 diabetes
  • •Severe hepatic insufficiency
  • •Active cancer
  • •eGFR\<30 ml/min

Outcomes

Primary Outcomes

Not specified

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