Clinical Trials Register

Summary
EudraCT Number:	2010-023394-19
Sponsor's Protocol Code Number:	9129
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-11-17
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

Netherlands - Competent Authority

A.2

EudraCT number

2010-023394-19

A.3

Full title of the trial

Early Beta blocker Administration before reperfusion in patients with ST-Elevation Myocardial Infarction who are planned to undergo primary PCI

A.3.1

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

Early Beta blocker Administration before reperfusion in patients with a myocardial infarction who are planned to undergo a percutaneous coronary intervention within 12 hours

A.3.2

Name or abbreviated title of the trial where available

Early-ßAMI

A.4.1

Sponsor's protocol code number

9129

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	Maatschap Cardiologie Isala
B.1.3.4	Country	Netherlands
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	Medtronic
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Medtronic
B.5.2	Functional name of contact point	B, van de Kerkhof
B.5.3	Address:
B.5.3.1	Street Address	Earl Bakkenstraat 10
B.5.3.2	Town/ city	Heerlen
B.5.3.3	Post code	6422 PJ
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	0031455668000
B.5.5	Fax number	0031455668668

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	metoprolol tartraat
D.2.1.1.2	Name of the Marketing Authorisation holder	RVG08700
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	Selokeen
D.3.2	Product code	rvg 08700
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
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	Solution for injection
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with acute ST elevation myocardial infarction, scheduled for emergency coronary angioplasty

E.1.1.1

Medical condition in easily understood language

Patients with an acute myocardial infarction, scheduled for emergency coronary angioplasty

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	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10066641
E.1.2	Term	Acute myocardial infarction, of anterior wall
E.1.2	System Organ Class	100000004849

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this randomized trial is to assess the beneficial effects of early administration of 5 mg Metoprolol intravenously and additional a second bolus of 5 mg in cathlab before reperfusion on infarct size in patients with ST elevation myocardial infarction who are planned to undergo primary PCI (PCI)

E.2.2

Secondary objectives of the trial

Troponin-T after 24 hour of hospitalization
Peak CK within hospitalization period
Area under CK and CK-MB curve within hospitalization period.
Residual ST deviation 1 hr after CAG/PCI
Ventricular Fibrillation requiring defibrillation during transportation and hospitalisation
MACE at 30 days and one year FUP
Safety End Points
The incidence of severe bradycardia, asthma or cardiogenic shock
30 day and one year total Mortality

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Zotarolimus eluting stent compared with GENOUS stent in patients with ST-elevation myocardial infarction undergoing primary PCI.

E.3

Principal inclusion criteria

• Patients ≥ 18 years of age with symptoms of acute ST-elevation myocardial infarction of more than 30 min but less than 12 hours and on the ECG ST-segment elevation of >= 0.1 mV in two adjacent limb electrocardiograph (ECG) leads and >= 0.2 mV in two adjacent precordial ECG leads or new left bundle branch block (LBBB).
• Verbal followed by written informed consents.
• PCI-center located within 90 minutes

E.4

Principal exclusion criteria

• Severe Hypotension (systolic blood pressure < 100 mmHg)
• Cardiogenic shock (severe dyspnoea, hypotension and oxygen saturation <92%, systolic blood pressure < 100 mmHg and heartrate > 110/min)
• Known with asthma
• Severe bradycardia at sinusrythm (< 60 bpm)
• PR interval >240 ms or second- and/or third degree atrio-ventricular (AV) block
• History of previous myocardial infarction
• Killip class III-IV
• Pacemaker/implantable cardioverter defibrillator (ICD)
• Unable to provide informed consent
• Patient is pregnant or breastfeeding

E.5 End points

E.5.1

Primary end point(s)

Infarct size as measured by MRI.

E.5.1.1

Timepoint(s) of evaluation of this end point

1 month after the myocardial infarction

E.5.2

Secondary end point(s)

Troponin-T after 24 hour of hospitalization
Peak CK within hospitalization period
Area under CK and CK-MB curve within hospitalization period.
Residual ST deviation 1 hr after CAG/PCI
Ventricular Fibrillation requiring defibrillation during
transportation and hospitalization
MACE at 30 days and one year FUP

E.5.2.1

Timepoint(s) of evaluation of this end point

Hospitalization and 30 day fup and one year fup

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

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

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

Yes

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

see protocol

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:

301

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

300

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

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

601

F.4.2

For a multinational trial

F.4.2.1

In the EEA

601

F.4.2.2

In the whole clinical trial

601

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)

None

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

2012-11-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-01-18

P. End of Trial
P.	End of Trial Status	Completed

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