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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01226563




Registration number
NCT01226563
Ethics application status
Date submitted
20/10/2010
Date registered
22/10/2010
Date last updated
27/02/2023

Titles & IDs
Public title
IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction
Scientific title
A Placebo Controlled, Multicenter, Randomized Double Blind Trial to Evaluate the Safety and Effectiveness of IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction
Secondary ID [1] 0 0
IK-5001-VENREM-201
Universal Trial Number (UTN)
Trial acronym
PRESERVATION-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction 0 0
Congestive Heart Failure 0 0
ST-Elevation Myocardial Infarction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - IK-5001
Treatment: Devices - Saline Solution

Experimental: IK-5001 - IK-5001 Sodium Alginate Calcium Gluconate intracoronary injection

Placebo Comparator: Saline Solution - Saline Solution intracoronary injection


Treatment: Devices: IK-5001
4 mL (+/- 0.2 mL) administered through intracoronary slow bolus injection over 15 to 30 seconds at least 2 days after PCI but within 5 days of onset of symptoms.

Treatment: Devices: Saline Solution
4 mL (+/- 0.2 mL) slow bolus, intracoronary injection of saline solution will be administered over 15 to 30 seconds at least 2 days after percutaneous coronary intervention (PCI) but within 5 days of onset of symptoms.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Left Ventricular End Diastolic Volume Index
Timepoint [1] 0 0
Baseline, 6 Months
Secondary outcome [1] 0 0
Kansas City Cardiomyopathy Questionaire
Timepoint [1] 0 0
Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits
Secondary outcome [2] 0 0
Six minute walk test
Timepoint [2] 0 0
Baseline (prior to discharge STEMI), 1, 3, 6 and 12 month follow-up visits
Secondary outcome [3] 0 0
New York Heart Association (NYHA) functional classification (Physician reported)
Timepoint [3] 0 0
Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits
Secondary outcome [4] 0 0
Cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations
Timepoint [4] 0 0
5 Years
Secondary outcome [5] 0 0
Re-hospitalization due to any cardiovascular event
Timepoint [5] 0 0
5 Years

Eligibility
Key inclusion criteria
Inclusion criteria:

Subjects must meet all of the following inclusion criteria to participate in this trial:

1. The subject is = 18 years of age.

2. The subject has given informed consent.

3. The subject has experienced a large STEMI defined by the following criteria:

Peak cardiac enzyme value within 48 hours of symptom onset as follows:

- Creatine kinase MB fraction (CK-MB) > 30 x the upper limit of normal OR

- Troponin I > 200 x upper limit of normal OR

- Troponin T > 60 x the upper limit of normal

AND at least 1 of the following 3 criteria:

- Delayed presentation with PCI > 6 hours from onset of symptoms

- Significant new Q waves in = 2 anterior leads or anterior ST segment elevation of
at least 3 mm persistent at 24 hours after PCI

- New onset of CHF (Killip class 3-4) or cardiogenic shock persistent at 24 hours
after PCI

AND at least 1 of the following 2 criteria:

- MI = 20% by Single Photon Emission Computed Tomography scan (SPECT) or cardiac
Magnetic Resonance Imaging (MRI) with defect in the appropriate distribution

- Ejection fraction = 35% with wall motion abnormality in the appropriate
distribution at baseline imaging assessment

4. The subject has had successful PCI with stent within 48 hours of symptom onset, and
residual stenosis less than 20% in the infarct related artery and greater than or
equal to thrombolysis in myocardial infarction (TIMI) 2 flow. Subjects undergoing
rescue PCI after thrombolysis or delayed presentation with ongoing ischemia may be
enrolled.

5. For Germany only: Patients determined to have Killip class 4 at time of device
deployment are not eligible for randomization.

6. For Germany only: If SPECT is used for determination of MI size in order to meet
inclusion criteria, the SPECT must have been previously performed as part of standard
clinical care. SPECT is not to be performed solely to qualify a patient for this study
in Germany.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

Subjects will be excluded from participating in this trial if ANY of the following
exclusion criteria are met:

1. Any subject with cardiogenic shock requiring mechanical ventilation or mechanical
support at the time of deployment. Subject must be off mechanical support prior to
deployment.

2. Need for urgent coronary artery bypass graft (CABG)

3. Clinically significant valvular heart disease with planned surgical correction or
transcatheter aortic valve implantation (TAVI)

4. Uncontrolled ventricular arrhythmias

5. Renal insufficiency with a calculated creatinine clearance of less than 30 mL/ minute.
See Appendix A for determining estimated creatinine clearance.

6. Clinically significant hepatic insufficiency

7. Inadequate imaging windows (defined as the inability to visualize the endocardial
border of at least 16 of the 17 segments in both the apical four chambers and apical
two chamber views without foreshortening) or arrhythmia that would preclude adequate
3D imaging on transthoracic echocardiography at the local baseline echo assessment

8. Non-ambulatory prior to the index MI

9. The subject has participated in another trial of an investigational agent within 30
days prior to randomization.

10. Subject has received resorbable stent as part of PCI.

11. The subject is pregnant or breastfeeding. Women of child-bearing potential will have a
negative urine pregnancy test prior to randomization.

12. Any other concurrent condition that, in the opinion of the investigator, would prevent
completion of the clinical trial, including inability to comply with follow up
requirements.

13. For Germany only: In the investigator's opinion, the patient is not expected to
survive =12 months.

14. For Germany only: 24 hours prior to device deployment, the patient has a serum calcium
level greater than the upper limit of normal as determined by the local laboratory.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
303
Recruitment in Australia
Recruitment state(s)
BrisbaneQLD,SA,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Gold Coast Hospital - Southport
Recruitment hospital [3] 0 0
The Queen Elisabeth Hospital - Woodville South
Recruitment hospital [4] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
The Northern Hospital - Melbourne
Recruitment hospital [6] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [7] 0 0
Royal Perth Hospital - Dept. of Cardiology - Perth
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3076 - Melbourne
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Rhode Island
Country [13] 0 0
Belgium
State/province [13] 0 0
Antwerpen
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussel
Country [15] 0 0
Belgium
State/province [15] 0 0
Genk
Country [16] 0 0
Belgium
State/province [16] 0 0
Liege
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
Nova Scotia
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Montreal
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
France
State/province [22] 0 0
Brive la Gaillarde
Country [23] 0 0
France
State/province [23] 0 0
Creteil Cedex
Country [24] 0 0
France
State/province [24] 0 0
Dijon Cedex
Country [25] 0 0
France
State/province [25] 0 0
Grenoble Cedex 09
Country [26] 0 0
France
State/province [26] 0 0
Lille
Country [27] 0 0
France
State/province [27] 0 0
Nice Cedex 1
Country [28] 0 0
France
State/province [28] 0 0
Paris
Country [29] 0 0
France
State/province [29] 0 0
Strasbourg Cedex
Country [30] 0 0
France
State/province [30] 0 0
Toulouse
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Erfurt
Country [33] 0 0
Germany
State/province [33] 0 0
Essen
Country [34] 0 0
Germany
State/province [34] 0 0
Heidelberg
Country [35] 0 0
Germany
State/province [35] 0 0
Jena
Country [36] 0 0
Germany
State/province [36] 0 0
Kiel
Country [37] 0 0
Germany
State/province [37] 0 0
Leipzig
Country [38] 0 0
Germany
State/province [38] 0 0
Lubeck
Country [39] 0 0
Germany
State/province [39] 0 0
Ludwigshafen
Country [40] 0 0
Germany
State/province [40] 0 0
Mannheim
Country [41] 0 0
Germany
State/province [41] 0 0
Munchen
Country [42] 0 0
Germany
State/province [42] 0 0
Neuss
Country [43] 0 0
Germany
State/province [43] 0 0
Oldenburg
Country [44] 0 0
Germany
State/province [44] 0 0
Siegen
Country [45] 0 0
Germany
State/province [45] 0 0
Trier
Country [46] 0 0
Germany
State/province [46] 0 0
Wuppertal
Country [47] 0 0
Israel
State/province [47] 0 0
Tel Aviv
Country [48] 0 0
Israel
State/province [48] 0 0
Afula
Country [49] 0 0
Israel
State/province [49] 0 0
Ashkelon
Country [50] 0 0
Israel
State/province [50] 0 0
Haifa
Country [51] 0 0
Israel
State/province [51] 0 0
Jerusalem
Country [52] 0 0
Israel
State/province [52] 0 0
Rehovot
Country [53] 0 0
Israel
State/province [53] 0 0
Tel Hashomer
Country [54] 0 0
Poland
State/province [54] 0 0
Gdansk
Country [55] 0 0
Poland
State/province [55] 0 0
Krakow
Country [56] 0 0
Poland
State/province [56] 0 0
Kraków
Country [57] 0 0
Poland
State/province [57] 0 0
Lodz
Country [58] 0 0
Poland
State/province [58] 0 0
Lublin
Country [59] 0 0
Poland
State/province [59] 0 0
Szczecin
Country [60] 0 0
Poland
State/province [60] 0 0
Warsaw
Country [61] 0 0
Poland
State/province [61] 0 0
Warszawa
Country [62] 0 0
Spain
State/province [62] 0 0
Barcelona
Country [63] 0 0
Spain
State/province [63] 0 0
Huelva
Country [64] 0 0
Spain
State/province [64] 0 0
Madrid
Country [65] 0 0
Spain
State/province [65] 0 0
Santiago

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bellerophon BCM LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for
the prevention of ventricular remodeling and congestive heart failure when administered to
subjects who had successful percutaneous coronary intervention with stent placement after ST
segment elevation MI (STEMI).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01226563
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ashika Ahmed, MD
Address 0 0
Bellerophon Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01226563