Clinical Trials Register

Summary
EudraCT Number:	2008-007290-20
Sponsor's Protocol Code Number:	TMC-BIV-08-03
National Competent Authority:	Slovenia - JAZMP
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-09-17
Trial results	View 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

Slovenia - JAZMP

A.2

EudraCT number

2008-007290-20

A.3

Full title of the trial

European Ambulance Acute Coronary Syndrome Angiox Trial: EUROMAX

Klinicno preskušanje European Ambulance Acute Coronary Syndrome Angiox Trial:EUROMAX

A.3.1

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

European Ambulance Acute Coronary Syndrome Angiox Trial: EUROMAX

Klinicno preskušanje European Ambulance Acute Coronary Syndrome Angiox Trial:EUROMAX

A.3.2

Name or abbreviated title of the trial where available

EUROMAX

A.4.1

Sponsor's protocol code number

TMC-BIV-08-03

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	The Medicines Company UK Ltd
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	The Medicines Company UK Ltd
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	The Medicines Company UK Ltd
B.5.2	Functional name of contact point	Sponsor
B.5.3	Address:
B.5.3.1	Street Address	115L Milton Park
B.5.3.2	Town/ city	Abingdon
B.5.3.3	Post code	OX14 4SA
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+441235448500
B.5.5	Fax number	+441235835561
B.5.6	E-mail	diana.schuette@themedco.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	Angiox
D.2.1.1.2	Name of the Marketing Authorisation holder	The Medicines Company UK Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Angiox
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BIVALIRUDIN
D.3.9.1	CAS number	128270-60-0
D.3.9.4	EV Substance Code	SUB05862MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	250
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Any unfractionated heparin with marketing authorization in Slovenia for anticoagulation in Patients with STE-ACS can be used as comparator for this trial
D.2.1.2	Country which granted the Marketing Authorisation	Slovenia
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	Heparin
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	9005-49-6
D.3.9.3	Other descriptive name	HEPARIN
D.3.9.4	EV Substance Code	SUB02475MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients presenting with ST-segment elevation acute coronary syndrome
(STE-ACS) planned for primary percutaneous coronary itervention (PCI)
management strategy

E.1.1.1

Medical condition in easily understood language

Patients presenting with ST-segment elevation acute coronary syndrome
(STE-ACS) planned for primary percutaneous coronary itervention (PCI)
management strategy

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10051592
E.1.2	Term	Acute coronary syndrome
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10041894
E.1.2	Term	ST segment elevation
E.1.2	System Organ Class	10022891 - Investigations

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 show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in patients with ST segment elevation acute coronary syndrome (STE-ACS), intended for a primary percutaneous coronary intervention (PCI) management
strategy, presenting either via ambulance or to centres where PCI is not performed.

Pokazati, da zgodnje zdravljenje z bivalirudinom izboljša izide ob 30. dnevu v primerjavi s trenutnim standardnim zdravljenjem bolnikov z akutnim koronarnim sindromom z dvigom ST veznice (STE-ACS), ki
so predvideni za nacin zdravljenja s primarno perkutano koronarno angioplastiko (PCI) in ki prejmejo prvo oskrbo preko reševalcev ali v zdravstvenih ustanovah, kjer ne izvajajo PCI.

E.2.2

Secondary objectives of the trial

Not applicable

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

ST segment resolution sub-analysis

Podanaliza normalizacije ST veznice

E.3

Principal inclusion criteria

1. Provide written informed consent before initiation of any study related procedures.
Patients randomised in the ambulance may initially sign an abridged version.
2. Be aged ≥18 years at the time of randomisation.
3. Have a presumed diagnosis of a STE-ACS with onset of symptoms of >20 minutes and <12 hours with one or more of the following:
 ST segment elevation of ≥1 mm in ≥2 contiguous leads
 Presumably new left bundle branch block
 An infero-lateral MI with ST segment depression of ≥1 mm in ≥2 of leads V1-3) with a positive terminal T wave
4. All patients must be scheduled for angiography +/- PCI (if indicated) <2 hours after first medical contact

E.4

Principal exclusion criteria

1. Any bleeding diathesis or severe haematological disease or history of intra-cerebral mass,aneurysm, arterio-venous malformation, haemorrhagic stroke, intra-cranial haemorrhage or gastrointestinal or genitourinary bleeding within the last 2-weeks.
2. Patients who have undergone recent surgery (including biopsy) within the last two weeks.
3. Patients on warfarin (not applicable if INR known to be <1.5).
4. Patients who have received UFH, LMWH or bivalirudin immediately before
randomisation.
5. Thrombolytic therapy within the last 48 hours.
6. Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast or to any of the study medications including aspirin or clopidogrel.
7. Contraindications to angiography, including but not limited to severe peripheral vascular disease.
8. If it is known pregnant or nursing mothers. Women of child-bearing age will be asked if they are pregnant or think that they may be pregnant.
9. If it is known a creatinine clearance <30 mL/min or dialysis dependent.
10. Previous enrolment in this study.
11. Treatment with other investigational drugs or devices within the 30 days preceding randomisation or planned use of other investigational drugs or devices in this trial.
12. Patients may not be enrolled if the duration of randomised investigational medicinal product (IMP) anti-thrombin infusion is likely to be less than 30 minutes from the time of onset to the commencement of angiography.
13. Patients may not be enrolled within a primary PCI capable hospital (unless at the time of randomisation the catheter laboratory is not available and the patient requires transfer to another primary PCI capable hospital).
14. Estimated body weight of >120 kg.

E.5 End points

E.5.1

Primary end point(s)

A composite of death, and non-CABG-related protocol major bleeding

Sestavljen cilj: smrt in vecja krvavitev, ki ni povezana s CABG protokolom

E.5.1.1

Timepoint(s) of evaluation of this end point

30 days

30. dnevu;

E.5.2

Secondary end point(s)

 Death or re-infarction (MI) at 30 days
 Death at 30 days and 365 days
 Re-infarction (MI) at 30 days
 IDR at 30 days
 Death, re-infarction (MI) or IDR at 30 days
 Death, re-infarction (MI) or non-CABG-related protocol major bleeding at 30 days
 Major bleeding at 30 days (protocol, TIMI and GUSTO)
 Minor bleeding at 30 days (protocol, TIMI, and GUSTO)
 Incidence of thrombocytopenia post index procedure and at 30 days
 Stent thrombosis (ARC definition) within 30 days
 Stroke at 30 days

• Smrt ali ponovni miokardni infarkt (MI) ob 30. dnevu;
• Smrt ob 30. dnevu in 365. dnevu;
• Ponovni miokardni infarkt (MI) ob 30. dnevu;
• Smrt, ponovni miokardni infarkt (MI) ali IDR ob 30. Dnevu Ponovna potreba po revaskularizaciji zaradi ishemije (IDR) ob 30. dnevu.;
• Smrt, ponovni miokardni infarkt (MI) ali vecja krvavitev, ki ni povezana s CABG protokolom ob 30. dnevu;
• Vecja krvavitev ob 30. dnevu (protokol, TIMI in GUSTO);
• Manjša krvavitev ob 30. dnevu (protokol, TIMI in GUSTO);
• Pogostnost pojava trombocitopenije po zacetnem posegu ter ob 30. dnevu;
• Tromboza v stentu (ARC definicija) ob 30. dnevu.Možganska kap ob 30. dnevu

E.5.2.1

Timepoint(s) of evaluation of this end point

30 days, 365 days

30. dnevu, 365. dnevu

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

Yes

E.8.2.2

Placebo

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

120

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

LVLS

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:

200

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

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

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

400

F.4.2

For a multinational trial

F.4.2.1

In the EEA

2200

F.4.2.2

In the whole clinical trial

2200

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)

On discharge, for all Patients in whom PCI was performed,standard treatment with aspirin (75-100 mg/day) and P2Y12 receptor blocker (including clopidogrel 75 mg daily) should be continued as per ECS guidelines preferably for one year.

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

2012-09-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-07-18

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

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