Clinical Trials Register

Summary
EudraCT Number:	2009-016954-42
Sponsor's Protocol Code Number:	SCT-Cpx-001
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:	2010-09-28
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

2009-016954-42

A.3

Full title of the trial

Randomized Clinical Safety and Efficacy Investigation of the Swiss Cardio Technologies Cardioplexol Solution in comparison with Buckberg Solution

A.3.1

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

Comparison of two cardiac protections techniques during cardiac surgery

A.3.2

Name or abbreviated title of the trial where available

Cardioplexol Study

A.4.1

Sponsor's protocol code number

SCT-Cpx-001

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	Berne
B.5.3.3	Post code	CH-3005
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	0041316322373
B.5.5	Fax number	0041316329766
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
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intracoronary 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

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 Cardioplexol 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 Cardioplexol

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. The patient is between the age of 18 and 80;
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 is carried out via a full sternotomy, under cardiac arrest and under the assistance of a heart lung machine;
4. The patient has signed the Patient Informed Consent Form.

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.

E.5.1.1

Timepoint(s) of evaluation of this end point

6, 12, 24, hours after myocardial 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.

E.5.2.1

Timepoint(s) of evaluation of this end point

Most secondary endpoints are measured during surgery or during the first 24 hours following myocardial reperfusion (details are described under E.5.2)

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

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

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

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

Last contact with the last subject undergoing the 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

Number of subjects for this age range:

F.1.1.1

In Utero