Focus of Study is STEMIPhase 2NCT01977755

Phase 2 Clinical Proof-of-Concept Study of the Cardioprotective Properties of Danegaptide in ST Segment Elevation Myocardial Infarction

A Phase 2 study testing danegaptide in people with Focus of Study is STEMI, run by Zealand Pharma at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study explores the potential cardioprotective properties of danegaptide when administered to patients with ST-Segment elevation myocardial infarction. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Focus of Study is STEMI
What is being tested?: danegaptide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 591 participants
Where: 1 siteDenmark
Study dates: Nov 2013to 8 Jun 2016
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years
ST-segment elevation myocardial infarction
Acute onset of chest pain of < 12 hours duration

Who cannot join

Pregnancy
Known prior Myocardial Infarction in same area as present STEMI, known hypertrophic or dilated cardiomyopathy, or prior hospital admission for heart failure
Contraindication for cardiac MRI
Inability to understand information or provide informed consent

Trial locations and contacts

1 site in 1 country.

Denmark1 site

The Heart Center, Rigshospitalet, University of Copenhagen
Copenhagen, 2100

Other trials in Denmark

About this study

Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess Clinical Efficacy and Safety of Danegaptide in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

This study explores the potential cardioprotective properties of danegaptide when administered to patients with ST-Segment elevation myocardial infarction.

Conditions: Focus of Study is STEMI
Being tested: danegaptide, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

danegaptideDrug
PlaceboDrug

Study groups in NCT01977755
Study group	Role	What they receive
danegapetide high dose	Active comparator	7,5 mg bolus injection, followed by 22,5 mg infused over 6 hours Receives: Drug: danegaptide
danegaptide low dose	Active comparator	2,5 mg bolus injection, followed by 7,5 mg infused over 6 hours Receives: Drug: danegaptide
Placebo	Placebo comparator	bolus injection, followed by infused over 6 hours Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Myocardial Salvage Index
Myocardial Salvage Index as assessed by MRI and calculated as the difference between myocardial volume at risk and final infarct size in relation to myocardial volume at risk
Measured: 3 months

Secondary outcomes (3)

Relative Infarct size, Absolute Infarct size, Left Ventricular Ejection Fraction (LVEF), microvascular obstruction and infarct haemorrhage as determined by MRI
Measured: 3 months
Degree of ST-resolution and fraction of patients with 70 % ST-resolution measured by ECG 60 minutes post Percutaneous Coronary Intervention procedure
Measured: 60 minutes
Major Clinical Adverse Events including cardiac death, new or worsening heart failure and re-admission for heart failure
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 20138 Jun 2016

First posted7 Nov 2013 (estimated)
Study startNov 2013
Primary completion20 Dec 2015
Study completion8 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Focus of Study is STEMIStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 591 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01977755
Sponsor's protocol ID: 13-031
Status last verified: Jan 2016
First submitted: 30 Oct 2013
Last updated: 6 Apr 2018
Results posted: No
Data monitoring committee: Yes

Publications

Thomsen AF, Bertelsen L, Jons C, Jabbari R, Lonborg J, Kyhl K, Goransson C, Nepper-Christensen L, Atharovski K, Ekstrom K, Tilsted HH, Pedersen F, Kober L, Engstrom T, Vejlstrup N, Jacobsen PK. Scar border zone mass and presence of border zone channels assessed with cardiac magnetic resonance imaging are associated with ventricular arrhythmia in patients with ST-segment elevation myocardial infarction. Europace. 2023 Mar 30;25(3):978-988. doi: 10.1093/europace/euac256.
PubMed 36576342
Engstrom T, Nepper-Christensen L, Helqvist S, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Tilsted HH, Steensberg A, Fabricius S, Mouritzen U, Vejlstrup N, Ahtarovski KA, Goransson C, Bertelsen L, Kyhl K, Olivecrona G, Kelbaek H, Lassen JF, Kober L, Lonborg J. Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients: a phase 2 randomised clinical trial. Heart. 2018 Oct;104(19):1593-1599. doi: 10.1136/heartjnl-2017-312774. Epub 2018 Mar 30.
PubMed 29602883

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess Clinical Efficacy and Safety of Danegaptide in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
ClinicalTrials.gov ID: NCT01977755
Acronym / sponsor ID: 13-031
Conditions: Focus of Study is STEMI
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 591 participants (actual)
Lead sponsor: Zealand PharmaIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: 20 Dec 2015 (actual)
Study completion: 8 Jun 2016 (actual)
First posted: 7 Nov 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study explores the potential cardioprotective properties of danegaptide when administered to patients with ST-Segment elevation myocardial infarction.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
danegapetide high dose	Active comparator	Drug: danegaptide7,5 mg bolus injection, followed by 22,5 mg infused over 6 hours
danegaptide low dose	Active comparator	Drug: danegaptide2,5 mg bolus injection, followed by 7,5 mg infused over 6 hours
Placebo	Placebo comparator	Drug: Placebobolus injection, followed by infused over 6 hours

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age ≥ 18 years
ST-segment elevation myocardial infarction
Acute onset of chest pain of < 12 hours duration

Key exclusion criteria (4 listed)

Pregnancy
Known prior Myocardial Infarction in same area as present STEMI, known hypertrophic or dilated cardiomyopathy, or prior hospital admission for heart failure
Contraindication for cardiac MRI
Inability to understand information or provide informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
danegaptide	Drug	danegapetide high dose, danegaptide low dose
Placebo	Drug	Placebo

Primary outcome

Myocardial Salvage Index
Time frame: 3 months
Myocardial Salvage Index as assessed by MRI and calculated as the difference between myocardial volume at risk and final infarct size in relation to myocardial volume at risk

3 secondary outcomes

Relative Infarct size, Absolute Infarct size, Left Ventricular Ejection Fraction (LVEF), microvascular obstruction and infarct haemorrhage as determined by MRI
Time frame: 3 months
Degree of ST-resolution and fraction of patients with 70 % ST-resolution measured by ECG 60 minutes post Percutaneous Coronary Intervention procedure
Time frame: 60 minutes
Major Clinical Adverse Events including cardiac death, new or worsening heart failure and re-admission for heart failure
Time frame: 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
Derived from this study: PubMed 36576342Thomsen AF, Bertelsen L, Jons C, Jabbari R, Lonborg J, Kyhl K, Goransson C, Nepper-Christensen L, Atharovski K, Ekstrom K, Tilsted HH, Pedersen F, Kober L, Engstrom T, Vejlstrup N, Jacobsen PK. Scar border zone mass and presence of border zone channels assessed with cardiac magnetic resonance imaging are associated with ventricular arrhythmia in patients with ST-segment elevation myocardial infarction. Europace. 2023 Mar 30;25(3):978-988. doi: 10.1093/europace/euac256.
Derived from this study: PubMed 29602883Engstrom T, Nepper-Christensen L, Helqvist S, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Tilsted HH, Steensberg A, Fabricius S, Mouritzen U, Vejlstrup N, Ahtarovski KA, Goransson C, Bertelsen L, Kyhl K, Olivecrona G, Kelbaek H, Lassen JF, Kober L, Lonborg J. Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients: a phase 2 randomised clinical trial. Heart. 2018 Oct;104(19):1593-1599. doi: 10.1136/heartjnl-2017-312774. Epub 2018 Mar 30.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Engstrom, MD, DMSci principal investigator

The Heart Center, Rigshopitalet University of Copenhagen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing danegaptide in people with Focus of Study is STEMI, run by Zealand Pharma at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial Salvage Index (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01977755, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.