VIldagliptin as an ischemic PERconditioning mimetic agent in Acute Myocardial Infarction - VIPER–AMI trial

VIldagliptin as an ischemic PERconditioning mimetic agent in Acute Myocardial Infarction – A single centre, randomized, parallel-group, double-blind clinical trial, for assessing the effectiveness of pharmacological myocardial conditioning in STEMI using vildagliptin.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001205-41-PT

Enrollment

128

Registered

2014-10-20

Start date

2015-01-09

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST Elevation Myocardial Infarction MedDRA version: 17.1 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Galvus Product Name: Galvus Pharmaceutical Form: Tablet INN or Proposed INN: VILDAGLIPTIN CAS Number: 274901-16-5 Concentration unit: mg milligram(s) Concentration type: equal Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - = 18 years old - STEMI presenting =65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: - Killip III-IV class STEMI - Blood glucose level at admission 1 on angiography - Unable to consent; - Female pregnant or breast feeding; - History of acute or chronic pancreatitis.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of oral vildagliptin, at a dose of 50mg twice daily, in increasing salvaged myocardium in patients presenting with STEMI (ST elevation myocardial infarction) and who are submitted to primary percutaneous coronary intervention.;Secondary Objective: - To determine if oral vildagliptin, at a dose of 50mg twice daily, in patients with STEMI who are submitted to p-PCI, improves left ventricle ejection fraction recovery between the first 5 days post-infarction and after 3 months - To determine if oral vildagliptin, at a dose of 50mg twice daily, in patients with STEMI who are submitted to p-PCI, is associated with a reduction of a composite hard clinical end point: death/reinfarction/re-admission due to heat failure at 12 months - To determine if oral vildagliptin, at a dose of 50mg twice daily, in patients with STEMI who are submitted to p-PCI, is associated with an improved functional capacity assessed with NYHA functional class after 3 and 12months, in patients developing post-infarction heart failure - To determine if oral vildagliptin, at a dose of 50mg twice daily, in patients with STEMI who are submitted to p-PCI, is associated with a lower risk of ventricular arrhythmias during hospitalization.;Primary end point(s): Initiation of oral vildagliptin as soon as possible, but before p-PCI, and continued for 5 days, twice daily, in STEMI patients (either diabetic or not) will result in an increased myocardial salvage, assessed with cardiac magnetic resonance imaging (c-MRI) performed at 3 months post-infarction. ;Timepoint(s) of evaluation of this end point: Cardiac magnetic resonance imaging (c-MRI) performed at 3 months post-infarction.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of oral vildagliptin, at a dose of 50mg twice daily, in increasing salvaged myocardium in patients presenting with STEMI (ST elevation myocardial infarction) and who are submitted to primary percutaneous coronary intervention.;Secondary Objective: - To determine if oral vildagliptin, at a dose of 50mg twice daily, in patients with STEMI who are submitted to p-PCI, improves left ventricle ejection fraction recovery between the first 5 days post-infarction and after 3 months - To determine if oral vildagliptin, at a dose of 50mg twice daily, in patients with STEMI who are submitted to p-PCI, is associated with a reduction of a composite hard clinical end point: death/reinfarction/re-admission due to heat failure at 12 months - To determine if oral vildagliptin, at a dose of 50mg twice daily, in patients with STEMI who are submitted to p-PCI, is associated with an improved functional capacity assessed with NYHA functional class after 3 and 12months, in patients developing post-infarction heart failure - To determine if oral vildagliptin, at a dose of 50mg twice daily, in patients with STEMI who are submitted to p-PCI, is associated with a lower risk of ventricular arrhythmias during hospitalization.;Primary end point(s): Initiation of oral vildagliptin as soon as possible, but before p-PCI, and continued for 5 days, twice daily, in STEMI patients (either diabetic or not) will result in an increased myocardial salvage, assessed with cardiac magnetic resonance imaging (c-MRI) performed at 3 months post-infarction. ;Timepoint(s) of evaluation of this end point: Cardiac magnetic resonance imaging (c-MRI) performed at 3 months post-infarction.

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Secondary

Measure	Time frame
Secondary end point(s): When compared to optimal standard medical therapy with p-PCI, in patients presenting with STEMI, immediate administration of vildagliptin will result in: - Reduced final infarct size, assessed with c-MRI at 3 months post-infarction - Reduction of infarct size evaluated by peak and AUC troponin I levels - Lower levels of peak plasma troponin and at 72h plasma troponin - Improvement of left ventricle ejection fraction recovery between the first five days post-infarction and after 3 months - Reduction of a composite hard clinical end point: death/reinfarction/re-admission due to heat failure at 12 months - Lower NYHA functional class after 3 and 12months, in patients developing post-infartion heart failure. ;Timepoint(s) of evaluation of this end point: - Reduced final infarct size, assessed with c-MRI at 3 months post-infarction - Reduction of infarct size evaluated by peak and AUC troponin I levels - Lower levels of peak plasma troponin and at 72h plasma troponin - Improvement of left ventricle ejection fraction recovery between the first five days post-infarction and after 3 months - Reduction of a composite hard clinical end point: death/reinfarction/re-admission due to heat failure at 12 months - Lower NYHA functional class after 3 and 12months, in patients developing post-infartion heart failure.	—

Measure

Time frame

Secondary end point(s): When compared to optimal standard medical therapy with p-PCI, in patients presenting with STEMI, immediate administration of vildagliptin will result in: - Reduced final infarct size, assessed with c-MRI at 3 months post-infarction - Reduction of infarct size evaluated by peak and AUC troponin I levels - Lower levels of peak plasma troponin and at 72h plasma troponin - Improvement of left ventricle ejection fraction recovery between the first five days post-infarction and after 3 months - Reduction of a composite hard clinical end point: death/reinfarction/re-admission due to heat failure at 12 months - Lower NYHA functional class after 3 and 12months, in patients developing post-infartion heart failure. ;Timepoint(s) of evaluation of this end point: - Reduced final infarct size, assessed with c-MRI at 3 months post-infarction - Reduction of infarct size evaluated by peak and AUC troponin I levels - Lower levels of peak plasma troponin and at 72h plasma troponin - Improvement of left ventricle ejection fraction recovery between the first five days post-infarction and after 3 months - Reduction of a composite hard clinical end point: death/reinfarction/re-admission due to heat failure at 12 months - Lower NYHA functional class after 3 and 12months, in patients developing post-infartion heart failure.

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Countries

Portugal

Contacts

Public ContactSérgio Leite

Centro Hospitalar de São João, EPE

vipertrial@outlook.com+351225512 100

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026