Clinical Trials Register

Summary
EudraCT Number:	2014-001205-41
Sponsor's Protocol Code Number:	VIPER–AMI
National Competent Authority:	Portugal - INFARMED
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2014-10-20
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Portugal - INFARMED

A.2

EudraCT number

2014-001205-41

A.3

Full title of the 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.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Avaliação da vildagliptina enquanto agente protetor do miocárdio no
enfarte agudo do miocárdio.

A.4.1

Sponsor's protocol code number

VIPER–AMI

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Sociedade Portuguesa de Cardiologia
B.1.3.4	Country	Portugal
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Novartis Farma - Produtos Farmacêuticos SA
B.4.2	Country	Portugal
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Centro Hospitalar de São João, EPE
B.5.2	Functional name of contact point	Sérgio Leite
B.5.3	Address:
B.5.3.1	Street Address	Alameda Hernâni Monteiro
B.5.3.2	Town/ city	Porto
B.5.3.3	Post code	4200-319
B.5.3.4	Country	Portugal
B.5.4	Telephone number	+351225512 100
B.5.5	Fax number	+351225025 766
B.5.6	E-mail	vipertrial@outlook.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Galvus
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Galvus
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VILDAGLIPTIN
D.3.9.1	CAS number	274901-16-5
D.3.9.4	EV Substance Code	SUB25199
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

ST Elevation Myocardial Infarction

E.1.1.1

Medical condition in easily understood language

Acute Myocardial Infarction

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	PT
E.1.2	Classification code	10000891
E.1.2	Term	Acute myocardial infarction
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

E.2.2

Secondary objectives of the trial

- 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.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- ≥ 18 years old
- STEMI presenting < 12h of symptoms
- Both genders
- Diabetic or non-diabetic patients
- Killip I-II class STEMI
- Able to understand and sign an informed consent form
- Females must be non-pregnant and non-lactating

E.4

Principal exclusion criteria

- Killip III-IV class STEMI
- Blood glucose level at admission <60mg/dL
- Previous MI; ACS???
- CKD or AKI at admission with GFR/creatinine clearance estimated to be <30ml/min
- Previous CABG; DPP-IV
- TIMI flow grade >1 on angiography
- Unable to consent;
- Female pregnant or breast feeding;
- History of acute or chronic pancreatitis.

E.5 End points

E.5.1

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.

E.5.1.1

Timepoint(s) of evaluation of this end point

Cardiac magnetic resonance imaging (c-MRI) performed at 3 months post-infarction.

E.5.2

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.

E.5.2.1

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.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The phone call visit (at 12 months post-infarction) of the last patient enrolled will mark the end of trial.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

Yes

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

128

F.4.2

For a multinational trial

F.4.2.1

In the EEA

128

F.4.2.2

In the whole clinical trial

128

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patients take the IMP only during hospitalization, after which patients maintain regular follow-up at Cardiology (not related to study participation).After 12 months of enrollment, a phone call is made (to assess living status) and participation in the trial ends.After this, the follow-up of the patient is left at the attending Cardiologist’s discretion. If the health status of the patient precludes a continuing specialized care then patients will continue to be followed at a Cardiology consult.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-11-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-01-09

P. End of Trial
P.	End of Trial Status	Ongoing

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