ST Elevation Myocardial InfarctionPhase 3HEAL-MINCT05881382
Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction
A Phase 3 study testing Dutogliptin + Filgrastim in people with ST Elevation Myocardial Infarction, run by Recardio, Inc..
Trial summary
The goal of this phase 3, randomized, double-blind, placebo-controlled clinical trial is to explore the safety and efficacy of dutogliptin administered subcutaneously (SC) in co-administration with filgrastim in adult patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- Dutogliptin + Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Sep 2025
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18 to 85 years (having reached 18 years of age and before having reached 86 years of age at the time of ICF signing)
- Able to provide written informed consent, including signing and dating the ICF
- STEMI is defined as follows:
- Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) AND
- Anterior STEMI:
- ECG Criteria
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- men > 40 years: ≥ 2 mm of new ST elevation in V2 and V3
- men ≤ 40 years: ≥ 2.5 mm of new ST elevation in V2 and V3
- women: ≥ 1.5 mm of new ST elevation in V2 and V3
- ECG Criteria
- o ≥ 1 mm of new ST elevation in two contiguous leads 4. STEMI must meet one of the following criteria:
- Anterior STEMI with thrombolysis in myocardial infarction (TIMI) 0 or 1 flow at presentation
- Non-anterior MI with the following:
- TIMI 0 flow at presentation AND
- Signs of HF, defined as at least one of the following radiographic evidence of pulmonary congestion, peripheral edema, increased jugular venous pressure, hepatojugular reflux or both, third heart sound or gallop 6. Female patients of childbearing potential must have a negative serum pregnancy test at Screening and an additional negative urine pregnancy test prior to the first dose of IMP unless regulated differently by national legislation.
Who cannot join
- Known significant pre-existing cardiomyopathy, moderate or severe mitral disease or aortic valvular disease
- Known pre-existing left ventricular ejection fraction < 40%
- Existing heart transplant
- Treatment with any dipeptidyl peptidase 4 (DPP4) inhibitors (eg, alogliptin, lingliptin, vildagliptin, saxagliptin, sitagliptin) or granulocyte colony-stimulation factor (G-CSF) medication (eg, filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim) within 4 months prior to randomization.
- Contraindication to treatment with filgrastim, including known allergy to filgrastim or other G-CSF medication
- Pregnant, planning to become pregnant, or nursing female patients
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- Known history of severe renal impairment or current renal impairment requiring dialysis
- History of pancreatitis (induced by high doses of DPP-4 inhibitors)
- Current or planned use of sulfonyl urea (risk of severe hypoglycemia)
- Any clinically significant abnormality identified prior to randomization that in the judgement of the Investigator or Sponsor that would preclude safe completion of the study, or confound the anticipated benefit of dutogliptin
About this study
Official title: Phase 3, Randomized, Double-blind, Placebo-controlled, Safety and Efficacy Study of Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction
The goal of this phase 3, randomized, double-blind, placebo-controlled clinical trial is to explore the safety and efficacy of dutogliptin administered subcutaneously (SC) in co-administration with filgrastim in adult patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).
The primary objective is to evaluate the efficacy of dutogliptin compared with placebo in STEMI patients within 180 days of randomization measured by the time of first occurrence of a composite endpoint of cardiovascular (CV) death and worsening heart failure (HF) within 180 days. Participants will receive dutogliptin twice daily subcutaneously (SC) for 14 days and filgrastim (SC) daily for 5 days or placebo.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- Dutogliptin + Filgrastim, Placebo
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dutogliptin + FilgrastimDrug
dutogliptin twice daily subcutaneously for 14 days and filgrastim daily subcutaneously for 5 days.
PlaceboDrug
Placebo dutogliptin twice daily subcutaneously for 14 days and placebo filgrastim daily subcutaneously for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Dutogliptin + Filgrastim | Active comparator | Participants will receive BID SC injections of 60 mg dutogliptin for 14 days in co-administration with 10 µg/kg filgrastim for 5 days. Receives: Drug: Dutogliptin + Filgrastim |
| Placebo-Dutogliptin + Placebo-Filgrastim | Placebo comparator | Randomized participants will receive BID SC injections of dutogliptin placebo for 14 days in co-administration with filgrastim placebo for 5 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of first occurence of the following composite endpoint of cardiovascular (CV) death and worsening of heart failure (HF)
defined as either an unplanned hospitalization or urgent visit resulting in intravenous therapy for heart failure
Measured: within 180 days of randomization
Secondary outcomes (3)
Time to cardiovascular death
defined as the time from randomization to the date of cardiovascular death
Measured: within 180 days of randomization
Worsening heart failure
defined as either an unplanned hospitalization or urgent visit resulting in intravenous therapy for heart failure
Measured: within 180 days of randomization
Total symptom score of the Kansas City Cardiomyopathy Questionnaire
Measured: at 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recardio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881382
- Sponsor's protocol ID
- REC-DUT-003
- Acronym
- HEAL-MI
- Status last verified
- Jun 2023
- First submitted
- 19 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Randomized, Double-blind, Placebo-controlled, Safety and Efficacy Study of Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction
- ClinicalTrials.gov ID
- NCT05881382
- Acronym / sponsor ID
- HEAL-MI / REC-DUT-003
- Conditions
- ST Elevation Myocardial Infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,100 participants (estimated)
- Lead sponsor
- Recardio, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 31 May 2023 (actual)
- 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.
The goal of this phase 3, randomized, double-blind, placebo-controlled clinical trial is to explore the safety and efficacy of dutogliptin administered subcutaneously (SC) in co-administration with filgrastim in adult patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).
The primary objective is to evaluate the efficacy of dutogliptin compared with placebo in STEMI patients within 180 days of randomization measured by the time of first occurrence of a composite endpoint of cardiovascular (CV) death and worsening heart failure (HF) within 180 days. Participants will receive dutogliptin twice daily subcutaneously (SC) for 14 days and filgrastim (SC) daily for 5 days or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dutogliptin + Filgrastim | Active comparator | Drug: Dutogliptin + FilgrastimParticipants will receive BID SC injections of 60 mg dutogliptin for 14 days in co-administration with 10 µg/kg filgrastim for 5 days. |
| Placebo-Dutogliptin + Placebo-Filgrastim | Placebo comparator | Drug: PlaceboRandomized participants will receive BID SC injections of dutogliptin placebo for 14 days in co-administration with filgrastim placebo for 5 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female, age 18 to 85 years (having reached 18 years of age and before having reached 86 years of age at the time of ICF signing)
- Able to provide written informed consent, including signing and dating the ICF
- STEMI is defined as follows:
- Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) AND
- ECG Criteria
Key exclusion criteria (10 listed)
- Known significant pre-existing cardiomyopathy, moderate or severe mitral disease or aortic valvular disease
- Known pre-existing left ventricular ejection fraction < 40%
- Existing heart transplant
- Treatment with any dipeptidyl peptidase 4 (DPP4) inhibitors (eg, alogliptin, lingliptin, vildagliptin, saxagliptin, sitagliptin) or granulocyte colony-stimulation factor (G-CSF) medication (eg, filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim) within 4 months prior to randomization.
- Contraindication to treatment with filgrastim, including known allergy to filgrastim or other G-CSF medication
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 |
|---|---|---|
| Dutogliptin + Filgrastimdutogliptin twice daily subcutaneously for 14 days and filgrastim daily subcutaneously for 5 days. | Drug | Dutogliptin + Filgrastim |
| PlaceboPlacebo dutogliptin twice daily subcutaneously for 14 days and placebo filgrastim daily subcutaneously for 5 days. | Drug | Placebo-Dutogliptin + Placebo-Filgrastim |
Primary outcome
Time of first occurence of the following composite endpoint of cardiovascular (CV) death and worsening of heart failure (HF)
Time frame: within 180 days of randomization
defined as either an unplanned hospitalization or urgent visit resulting in intravenous therapy for heart failure
3 secondary outcomes
Time to cardiovascular death
Time frame: within 180 days of randomization
Worsening heart failure
Time frame: within 180 days of randomization
Total symptom score of the Kansas City Cardiomyopathy Questionnaire
Time frame: at 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dutogliptin + Filgrastim in people with ST Elevation Myocardial Infarction, run by Recardio, Inc..
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 15 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Time of first occurence of the following composite endpoint of cardiovascular (CV) death and worsening of heart failure (HF) (time frame: within 180 days of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2023.