Non STEMIPhase 2CARINNCT02103959
Safety and Efficacy of CMX-2043 for Protection of the Heart and Kidneys in Subjects Undergoing Coronary Angiography
A Phase 2 study testing CMX-2043 in people with Non STEMI and Unstable Angina, run by Ischemix, LLC.
Trial summary
The objective of this study is to evaluate CMX-2043 for prevention of renal and cardiac injury associated with coronary angiography in patients with acute coronary syndrome (ACS), but excluding ST-elevation myocardial infarction (STEMI) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non STEMI, Unstable Angina
- What is being tested?
- CMX-2043
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 361 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2015
- 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
- Male or female subjects at least 18 years of age.
- Subjects with acute coronary syndrome (excluding STEMI).
- Subjects undergoing coronary angiography with the possibility of going on to PCI. However, if it is known that the patient is unlikely to undergo PCI, the patient should not be enrolled.
- Subjects must meet either one of the following criteria:
- An eGFR < 45 mL/min as determined by the MDRD equation
- An eGFR < 60 mL/min as determined by the MDRD equation and at least one of the following:
Show all 14Show fewer
- Over 75 years of age ii. Diabetes mellitus iii. Ejection fraction less than 40% iv. Hypotension v. Congestive heart failure (NYHA stage II or higher) vi. Anemia (hemoglobin below 10 g/dL at screening)
- Female subjects must also meet any one of the following criteria:
- Surgically sterile with bilateral tubal ligation or hysterectomy
- Post-menopausal for at least one year
- If of child-bearing potential, practicing an acceptable method of birth control for the duration of the study as judged by the investigator, such as condoms, foams, jellies, diaphragm, intrauterine device or abstinence.
- Subjects free of non-cardiac acute injuries or illnesses that, in the opinion of the investigator, could put the subject at risk or obscure the interpretation of results.
- Subjects willing to undergo pre-and post-study blood and urine collection, physical exams and laboratory investigations.
- Subjects willing to provide signed written informed consent form.
Who cannot join
- Subjects undergoing elective coronary angiography (i.e., stable angina).
- Subjects with end-stage renal disease (i.e., eGFR < 15).
- Subjects with ST-elevation myocardial infarction (STEMI)
- Subjects who experienced cardiac arrest associated with the current admission which required chest compressions or cardiopulmonary resuscitation.
- Subjects who experienced a life threatening arrhythmia associated with the current admission such as ventricular fibrillation or ventricular tachycardia.
- Subjects who weigh over 125 kg.
Show all 12Show fewer
- Subjects with an active history of psychiatric disorders likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements.
- Subjects with a history of alcohol or drug abuse within one year of screening.
- Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests which in the investigators opinion will interfere with the study conduct.
- Subjects with non-cardiac acute illness or injuries in which the investigator considers will increase the risk to the subject or to the study's success or which will obscure the interpretation of the results.
- Subject with chronic diseases considered by the investigator unfit for the procedure or which will increase the risk to the subject or to the study's success or which will obscure the interpretation of results.
- Subjects who are currently enrolled or who have participated in a clinical study within 30 days of screening or within 5 half-lives of another study drug, whichever is longer.
About this study
Official title: A Prospective, Comparative, Randomized, Multi-Center, Double-Blinded, Placebo-Controlled, Phase 2a Study of the Safety and Efficacy of CMX-2043 for Periprocedural Injury Protection in Subjects Undergoing Coronary Angiography at Risk of Radio-contrast Induced Nephropathy (CARIN)
The objective of this study is to evaluate CMX-2043 for prevention of renal and cardiac injury associated with coronary angiography in patients with acute coronary syndrome (ACS), but excluding ST-elevation myocardial infarction (STEMI) patients. This study will specifically examine the ability of CMX-2043 to prevent acute renal injury following coronary angiography. The study will also examine the ability of CMX 2043 for prevention of periprocedural cardiac injury. Information will be obtained relating to the ability of CMX 2043 for prevention of major adverse cardiac and renal events following the procedure. Additional information will be obtained in this study to evaluate safety of the drug. Dose and regimen information will also be obtained for future clinical studies of CMX-2043.
- Conditions
- Non STEMI, Unstable Angina
- Being tested
- CMX-2043, Placebo comparator
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMX-2043Drug
Slow bolus IV administration of CMX-2043
Placebo comparatorDrug
Slow bolus IV administration of PBS
| Study group | Role | What they receive |
|---|---|---|
| CMX-2043 2.4 mg/Kg | Experimental | Bolus injection of investigational product given prior to the cardiac catheterization and placebo given 24 hours after the first dose. Receives: Drug: CMX-2043 |
| CMX-2043 3.6 mg/kg | Experimental | Bolus injection of investigational product given prior to the cardiac catheterization and placebo given 24 hours after the first dose. Receives: Drug: CMX-2043 |
| CMX-2043 2.4 mg/kg given twice | Experimental | Bolus injection of investigational product given prior to the cardiac catheterization and again 24 hours after the first dose. Receives: Drug: CMX-2043 |
| Placebo comparator | Placebo comparator | Placebo comparator (PBS) given prior to cardiac catheterization and again 24 hours after the first dose. Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of acute kidney injury (AKI).
Reduction in the incidence of AKI as determined by the KDIGO definition of AKI compared to placebo.
Measured: Three days
Secondary outcomes (4)
Reduction in biomarkers of AKI
Reduction in renal injury as determined by renal biomarkers in the treatment groups compared to placebo.
Measured: Three days
Trends in clinical outcomes
Incidence of major adverse cardiac events (MACE) or major adverse kidney events (MAKE) or other clinical complications in the treatment groups compared to placebo.
Measured: 90 days
Prevention of cardiac injury in unstable angina (UA) subjects who go on to PCI.
Reduction in cardiac injury as determined by cardiac biomarkers in the treatment groups compared to placebo
Measured: Three days
Safety monitoring
Assessments of treatment emergent adverse events.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ischemix, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan S Lader, PhD, Study director, Ischemix, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103959
- Sponsor's protocol ID
- CMX-2043-2aK
- Acronym
- CARIN
- Status last verified
- Jun 2014
- First submitted
- 1 Apr 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Comparative, Randomized, Multi-Center, Double-Blinded, Placebo-Controlled, Phase 2a Study of the Safety and Efficacy of CMX-2043 for Periprocedural Injury Protection in Subjects Undergoing Coronary Angiography at Risk of Radio-contrast Induced Nephropathy (CARIN)
- ClinicalTrials.gov ID
- NCT02103959
- Acronym / sponsor ID
- CARIN / CMX-2043-2aK
- Conditions
- Non STEMI, Unstable Angina
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Ischemix, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Apr 2014 (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.
The objective of this study is to evaluate CMX-2043 for prevention of renal and cardiac injury associated with coronary angiography in patients with acute coronary syndrome (ACS), but excluding ST-elevation myocardial infarction (STEMI) patients. This study will specifically examine the ability of CMX-2043 to prevent acute renal injury following coronary angiography. The study will also examine the ability of CMX 2043 for prevention of periprocedural cardiac injury. Information will be obtained relating to the ability of CMX 2043 for prevention of major adverse cardiac and renal events following the procedure. Additional information will be obtained in this study to evaluate safety of the drug. Dose and regimen information will also be obtained for future clinical studies of CMX-2043.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CMX-2043 2.4 mg/Kg | Experimental | Drug: CMX-2043Bolus injection of investigational product given prior to the cardiac catheterization and placebo given 24 hours after the first dose. |
| CMX-2043 3.6 mg/kg | Experimental | Drug: CMX-2043Bolus injection of investigational product given prior to the cardiac catheterization and placebo given 24 hours after the first dose. |
| CMX-2043 2.4 mg/kg given twice | Experimental | Drug: CMX-2043Bolus injection of investigational product given prior to the cardiac catheterization and again 24 hours after the first dose. |
| Placebo comparator | Placebo comparator | Drug: Placebo comparatorPlacebo comparator (PBS) given prior to cardiac catheterization and again 24 hours after the first dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female subjects at least 18 years of age.
- Subjects with acute coronary syndrome (excluding STEMI).
- Subjects undergoing coronary angiography with the possibility of going on to PCI. However, if it is known that the patient is unlikely to undergo PCI, the patient should not be enrolled.
- Subjects must meet either one of the following criteria:
- Female subjects must also meet any one of the following criteria:
Key exclusion criteria (12 listed)
- Subjects undergoing elective coronary angiography (i.e., stable angina).
- Subjects with end-stage renal disease (i.e., eGFR < 15).
- Subjects with ST-elevation myocardial infarction (STEMI)
- Subjects who experienced cardiac arrest associated with the current admission which required chest compressions or cardiopulmonary resuscitation.
- Subjects who experienced a life threatening arrhythmia associated with the current admission such as ventricular fibrillation or ventricular tachycardia.
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 |
|---|---|---|
| CMX-2043Slow bolus IV administration of CMX-2043 | Drug | CMX-2043 2.4 mg/Kg, CMX-2043 2.4 mg/kg given twice, CMX-2043 3.6 mg/kg |
| Placebo comparatorSlow bolus IV administration of PBS | Drug | Placebo comparator |
Primary outcome
Prevention of acute kidney injury (AKI).
Time frame: Three days
Reduction in the incidence of AKI as determined by the KDIGO definition of AKI compared to placebo.
4 secondary outcomes
Reduction in biomarkers of AKI
Time frame: Three days
Trends in clinical outcomes
Time frame: 90 days
Prevention of cardiac injury in unstable angina (UA) subjects who go on to PCI.
Time frame: Three days
Safety monitoring
Time frame: 90 days
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 23 Feb 2016.
Related trials for Non STEMI
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Active, not recruiting
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Acute Myocardial Infarction, Coronary Artery Disease
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
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.
Alan S Lader, PhD study director
Ischemix, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CMX-2043 in people with Non STEMI and Unstable Angina, run by Ischemix, LLC.
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 14 inclusion and 12 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 23 Feb 2016. 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 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?
Prevention of acute kidney injury (AKI). (time frame: Three days). 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 23 Feb 2016.