Stable Coronary Artery DiseasePhase 2SUPPORT-1NCT00984802
Safety and Efficacy of CMX-2043 in Subjects Undergoing Coronary Reperfusion Therapy
A Phase 2 study testing CMX-2043 in people with Stable Coronary Artery Disease and Percutaneous Coronary Intervention, run by Ischemix, LLC at 5 sites in 2 countries.
Trial summary
This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV) injection, and to evaluate efficacy on the basis of the changes seen in the cardiac biomarkers and continuous electrocardiography (ECG) monitoring. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stable Coronary Artery Disease, Percutaneous Coronary Intervention
- 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
- 142 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Feb 2010to Apr 2011
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have stable coronary artery disease undergoing elective PCI.
- Female subjects not of child-bearing potential.
- Absence of ST segment depression >1.0 mm and absence of ST elevation >1.0 mm in any lead on the baseline 12-lead ECG.
- subjects with CK-MB and troponin-T levels lower than the upper limit of normal.
- Subjects free of acute injuries or illnesses.
Who cannot join
- Subjects with unstable angina (angina at rest, worsening frequency, duration of angina) or other signs of unstable coronary artery disease.
- Subjects who had had an MI within 14 days prior to the PCI procedure.
- Subjects with conditions that contraindicate the PCI (e.g. coagulopathy, valvular disease, PVD).
- Subjects with history of TIA/stroke within 90 days or any intracranial bleed.
- Subjects with creatinine clearance ≥ 1.5 times the upper limit of normal.
- Subjects with an active history of psychiatric disorders that is likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements.
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- Subjects with a history of alcohol or drug abuse.
- Subjects with documented history of human immunodeficiency virus (HIV), or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
- Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests who in the investigators opinion will interfere with the study conduct.
- Subject with chronic diseases considered by the anesthetist unfit for surgery and/or who in the opinion of the investigator will increase the risk of the study or obscure the interpretation of results.
- Subjects who have participated in a clinical study within 1 month or are currently participating in a clinical study of an investigational agent.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
India3 sites
Madras Medical Mission
Chennai, 600 037
Hinduja Hospital
Mumbai, 400 016
Poona Hospital
Pune, 411 030
United States2 sites
Duke University Hospital
Durham, North Carolina, 27705
St. Vincent Hospital
Worcester, Massachusetts, 01608
About this study
Official title: A Prospective, Randomized, Comparative, Blinded, Placebo-Controlled, Three Different Intravenous Dose, Phase 2a Study of the Safety and Efficacy of CMX-2043 in Subjects Undergoing PCI and Peri-Operative Reperfusion Treatment (SUPPORT-1)
This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV) injection, and to evaluate efficacy on the basis of the changes seen in the cardiac biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be explored.
- Being tested
- CMX-2043, Placebo control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMX-2043Drug
Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.
Placebo controlDrug
Vehicle solution for IV administration single dose.
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Not described Receives: Drug: CMX-2043 |
| Mid Dose | Experimental | Not described Receives: Drug: CMX-2043 |
| High Dose | Experimental | Not described Receives: Drug: CMX-2043 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by changes in CK-MB
Measured: within 24 hours
Secondary outcomes (2)
Cardiac biomarkers
Measured: within 24 hours
ST segment changes
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startFeb 2010
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Coronary Artery DiseaseStudies 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, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ischemix, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alan S. Lader, Ph.D., Study director, Ischemix, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984802
- Sponsor's protocol ID
- CMX-2043-2a
- Acronym
- SUPPORT-1
- Status last verified
- Jun 2011
- First submitted
- 23 Sep 2009
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Comparative, Blinded, Placebo-Controlled, Three Different Intravenous Dose, Phase 2a Study of the Safety and Efficacy of CMX-2043 in Subjects Undergoing PCI and Peri-Operative Reperfusion Treatment (SUPPORT-1)
- ClinicalTrials.gov ID
- NCT00984802
- Acronym / sponsor ID
- SUPPORT-1 / CMX-2043-2a
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Ischemix, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 Sep 2009 (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 is conducted to assess the safety of CMX-2043 solution for intravenous (IV) injection, and to evaluate efficacy on the basis of the changes seen in the cardiac biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: CMX-2043 |
| Mid Dose | Experimental | Drug: CMX-2043 |
| High Dose | Experimental | Drug: CMX-2043 |
| Placebo | Placebo comparator | Drug: Placebo control |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who have stable coronary artery disease undergoing elective PCI.
- Female subjects not of child-bearing potential.
- Absence of ST segment depression >1.0 mm and absence of ST elevation >1.0 mm in any lead on the baseline 12-lead ECG.
- subjects with CK-MB and troponin-T levels lower than the upper limit of normal.
- Subjects free of acute injuries or illnesses.
Key exclusion criteria (11 listed)
- Subjects with unstable angina (angina at rest, worsening frequency, duration of angina) or other signs of unstable coronary artery disease.
- Subjects who had had an MI within 14 days prior to the PCI procedure.
- Subjects with conditions that contraindicate the PCI (e.g. coagulopathy, valvular disease, PVD).
- Subjects with history of TIA/stroke within 90 days or any intracranial bleed.
- Subjects with creatinine clearance ≥ 1.5 times the upper limit of normal.
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-2043Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose. | Drug | High Dose, Low dose, Mid Dose |
| Placebo controlVehicle solution for IV administration single dose. | Drug | Placebo |
Primary outcome
Safety as measured by changes in CK-MB
Time frame: within 24 hours
2 secondary outcomes
Cardiac biomarkers
Time frame: within 24 hours
ST segment changes
Time frame: within 24 hours
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 20 Jun 2011.
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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.
Alan S. Lader, Ph.D. study director
Ischemix, LLC
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CMX-2043 in people with Stable Coronary Artery Disease and Percutaneous Coronary Intervention, run by Ischemix, LLC at 5 sites in 2 countries.
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 5 inclusion and 11 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 20 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India, United States. 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?
Safety as measured by changes in CK-MB (time frame: within 24 hours). 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 20 Jun 2011.