Clinical Trials Register

Summary
EudraCT Number:	2011-004198-10
Sponsor's Protocol Code Number:	SCT-Cpx-003
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-10-04
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

Austria - BASG

A.2

EudraCT number

2011-004198-10

A.3

Full title of the trial

A Single-Centre, Single Blind, Randomized, Active-Controlled Phase III Non-Inferiority Study to Investigate the Safety and Efficacy of the Cardioplegic Solution Cardioplexol when used during a Cardiac Surgical Intervention under the Assistance of a Heart-Lung Machine

A.3.1

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

Comparison of two cardiac protection techniques during cardiac surgery

A.4.1

Sponsor's protocol code number

SCT-Cpx-003

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	Swiss Cardio Technologies AG
B.1.3.4	Country	Switzerland
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	Swiss Cardio Technologies AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Swiss Cardio Technologies AG
B.5.2	Functional name of contact point	Hendrik Tevaearai
B.5.3	Address:
B.5.3.1	Street Address	Thunstrasse 42
B.5.3.2	Town/ city	Bern
B.5.3.3	Post code	3005
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	41316322373
B.5.5	Fax number	41316329766
B.5.6	E-mail	hendrik.tevaearai@swisscardiotech.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	No
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	Cardioplexol
D.3.2	Product code	Cpx
D.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intracoronary use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	7447-40-7
D.3.9.3	Other descriptive name	POTASSIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12559MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	10034-99-8
D.3.9.3	Other descriptive name	MAGNESIUM SULPHATE HEPTAHYDRATE
D.3.9.4	EV Substance Code	SUB12131MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	51-05-8
D.3.9.3	Other descriptive name	PROCAINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04046MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	87-99-0
D.3.9.3	Other descriptive name	XYLITOL
D.3.9.4	EV Substance Code	SUB15737MIG
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	71.1
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	No
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	Buckberg solution
D.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intracoronary use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	7447-40-7
D.3.9.3	Other descriptive name	POTASSIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12559MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	2.3 to 7.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	7647-14-5
D.3.9.3	Other descriptive name	SODIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12581MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.7 to 2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	77-86-1
D.3.9.3	Other descriptive name	TROMETAMOL
D.3.9.4	EV Substance Code	SUB11336MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5.3 to 8.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	50-99-7
D.3.9.3	Other descriptive name	GLUCOSE
D.3.9.4	EV Substance Code	SUB13981MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/ml gram(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	183.2 to 202.6
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Medical conditions necessitating an elective surgical coronary artery
bypass grafting (CABG) and/or a valve repair/replacement.

E.1.1.1

Medical condition in easily understood language

Patients requiring a cardiac surgical intervention

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

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 explore the effects of CardioplexolTM on the protection of cardiac cells during the “ischemic” period in order to allow a rapid and complete reversibility of the cardiac arrest when used during a cardiac surgical intervention under the assistance of a heart-lung machine.

E.2.2

Secondary objectives of the trial

- To explore the effects on duration in ICU stay and on duration of hospitalisation
- To evaluate the safety and tolerability of CardioplexolTM

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female patients between 18 and 80 years of age.
2. The patient’s preoperative evaluation indicates the need for a primary elective cardiac coronary artery bypass graft (CABG) operation and/or a cardiac valve repair/replacement;
3. The operation can be carried out via a full sternotomy, under cardiac arrest and under the assistance of a heart lung machine;
4. Patients (or legal representatives) who provide signed written informed consent.

E.4

Principal exclusion criteria

1. pre-operative EF of less than 30%;
2. pre-operative IABP;
3. under pre-operative catecholamine support;
4. history of myocardial infarction within less than 7 days;
5. previous history of cardiac surgery, including the implantation of a pace maker or an ICD;
6. active myocarditis and/or endocarditis;
7. history of atrial fibrillation;
8. aortic valve insufficiency severity grade > 1;
9. history of neurologic event;
10. carotid artery disease;
11. renal insufficiency or is under dialysis;
12. pre-operative serum creatinine value of more than 2.0 mg/dl;
13. known for an hematologic disorder;
14. under anti-vitamin K;
15. history of HIT;
16. participating in a concomitant research study of an investigational product;
17. pregnant or lactating;
18. intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent;

E.5 End points

E.5.1

Primary end point(s)

Maximal value of troponin-T (ng/ml) during the first 24 hours following myocardial reperfusion.

Primärer Zielparameter ist der maximal erreichte Troponin-T-Wert während der ersten 24 Stunden nach der myokardialen Reperfusion.

E.5.1.1

Timepoint(s) of evaluation of this end point

During the first 24 hours post-reperfusion

E.5.2

Secondary end point(s)

1. Maximal value of CK-MB during the first 24 hours following myocardial reperfusion.
2. Time between the aortic cross-clamping and the complete cardiac arrest.
3. Percentage of patients requiring catecholamines during aortic cross-clamping.
4. Cumulative dose of catecholamines during aortic cross-clamping.
5. Defibrillation rate after aorta unclamping and coronary reperfusion.
6. Cumulative dose of catecholamines during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours).
7. Percentage of patients requiring the installation of an IABP during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours).
8. Duration of intubation.
9. Duration of ICU stay.
10. Mortality during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours).
11. Maximal ST elevation during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours).
12. Duration of hospitalization.
Safety Endpoints:
1.Serious and non-serious adverse events.
2.Vital signs
3.Clinical laboratory data (haematology and blood chemistry).
4.12-lead electrocardiogram (ECG).

•Wirksamkeit: der maximal erreichte CK-MB-Wert während der ersten 24 Stunden nach der myokardialen Reperfusion, die Zeit zwischen Abklemmen der Aorta und komplettem Herzstillstand, Anteil der Patienten, die während des Abklemmens der Aorta Katecholamine benötigen, kumulative Katecholamindosis, Häufigkeit der Defibrillation nach koronarer Reperfusion, Anteil der Patienten, die während der ersten 24 Stunden nach Reperfusion eine intraaortale Ballonpumpe benötigen, Dauer der Intubation, Dauer des Aufenthalts auf der Intensivstation, Mortalität in den ersten 24 Stunden nach Reperfusion, maximale ST-Erhöhung in den ersten 24 Stunden nach Reperfusion, Dauer des Krankenhausaufenthalts

Verträglichkeit, Sicherheit: unerwünschte Ereignisse,Vitalzeichen, Laborwerte, EKG.

E.5.2.1

Timepoint(s) of evaluation of this end point

During the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours).
Safety is evaluated up to 30 days after the end of the surgery.

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

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

Yes

E.8.1.4

Double blind

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)

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in 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

Last visit of the last subject

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

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.1.3

Elderly (>=65 years)

Yes

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-10-04.

Yes

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

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

240

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)

No specific treatment others than expected treatment normally
provided in that condition

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

2012-03-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-16

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-08-03

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