Myocardial InfarctionPhase 2PROTECTION AMINCT00785954
Safety and Efficacy Study of KAI-9803 to Treat Subjects With ST Elevation Myocardial Infarction [Heart Attack]
A Phase 2 study testing KAI-9803 in people with Myocardial Infarction and Cardiovascular Diseases, run by KAI Pharmaceuticals at 126 sites in 18 countries.
Trial summary
The purpose of this study is to determine whether KAI-9803 is safe and effective in reducing infarct size in subjects with ST elevation myocardial infarction (heart attack) undergoing a percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Cardiovascular Diseases, Pathologic Processes
- What is being tested?
- KAI-9803
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,180 participants
- Where
- 126 sitesin 18 countries
- Study dates
- Nov 2008to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute STEMI and has a planned emergent primary PCI procedure
- Continuous symptoms of cardiac ischemia and present to the primary PCI facility within 6 hours of symptom onset
Who cannot join
- Persistent systolic blood pressure < 90 mm Hg
Trial locations and contacts
126 sites in 18 countries.
126 sites in 18 countries
United States17 sites
Study site
Atlanta, Georgia, 30309
Study site
Beaver, Pennsylvania, 15009
Study site
Danville, Pennsylvania, 17822
Study site
Downers Grove, Illinois, 60515
Study site
Escondido, California, 92025
Study site
Greensboro, North Carolina, 27410
Study site
High Point, North Carolina, 27262
Study site
Huntsville, Alabama, 35801
Study site
Lombard, Illinois, 60148
Study site
Oklahoma City, Oklahoma, 77030
Study site
Omaha, Nebraska, 68131
Study site
Peoria, Illinois, 61602
Study site
Tampa, Florida, 33613
Study site
Torrance, California, 90509
Study site
Valparaiso, Indiana, 46383
Study site
Williamsville, New York, 14221
Study site
Zanesville, Ohio, 43701
Australia11 sites
Study site
Bedford Park
Study site
Boxhill
Study site
Epping
Study site
Fremantle
Study site
Hobart
Study site
Kogarah
Study site
Liverpool
Study site
Parkville
Study site
Perth
Study site
St Leonards
Study site
Victoria
Poland11 sites
Study site
Bialystok
Study site
Bielsko-Biala
Study site
Dąbrowa Górnicza
Study site
Gdansk
Study site
Gdynia
Study site
Krakow
Study site
Lubin
Study site
Poznan
Study site
Szczecin
Study site
Torun
Study site
Warsaw
Canada10 sites
Study site
Edmonton, Alberta
Study site
Hamilton, Ontario
Study site
Kitchner, Ontario
Study site
Montreal, Quebec
Study site
New Brunswick
Study site
Newmarket, Ontario
Study site
Sainte-Foy, Quebec
Study site
Toronta, Ontario
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Czechia10 sites
Study site
Brno
Study site
Hradec Králové
Study site
Karlovy Vary
Study site
Labem
Study site
Liberec
Study site
Olomouc
Study site
Ostrava
Study site
Pilsen
Study site
Prague
Study site
Zlín
Germany9 sites
Study site
Berlin
Study site
Halle
Study site
Hamburg
Study site
Heidelberg
Study site
Lübeck
Study site
Magdeburg
Study site
Mannheim
Study site
München
Study site
Rostock
Israel9 sites
Study site
Afula
Study site
Ashkelon
Study site
BeerSheva
Study site
Haifa
Study site
Holon
Study site
Jerusalem
Study site
Kfar Saba
Study site
Safed
Study site
Tsrifin
Spain8 sites
Study site
Alicante
Study site
Barcelona
Study site
El Palmar Murcia
Study site
León
Study site
Madrid
Study site
Santa Cruz de Tenerife
Study site
Seville
Study site
Vigo Pontevedra
Sweden8 sites
Study site
Gothenburg
Study site
Helsingborg
Study site
Linköping
Study site
Lund
Study site
Malmö
Study site
Örebro
Study site
Stockholm
Study site
Sundsvall
Belgium5 sites
Study site
Antwerp
Study site
Bonheiden
Study site
Brussels
Study site
Liège
Study site
Roeselare
Hungary5 sites
Study site
Budapest
Study site
Pécs
Study site
Szeged
Study site
Székesfehérvár
Study site
Zalaegerszeg
New Zealand5 sites
Study site
Auckland
Study site
Christchurch
Study site
Dunedin
Study site
Hamilton
Study site
Nelson
Denmark4 sites
Study site
Aalborg
Study site
Copenhagen
Study site
Hellerup
Study site
Odense
Netherlands4 sites
Study site
Amsterdam
Study site
Nieuwegein
Study site
Rotterdam
Study site
Zwolle
About this study
Official title: Inhibition of Delta-protein Kinase C for the Reduction of Infarct Size in Acute Myocardial Infarction
The purpose of this study is to determine whether KAI-9803 is safe and effective in reducing infarct size in subjects with ST elevation myocardial infarction (heart attack) undergoing a percutaneous coronary intervention (PCI). A select number of sites will also participate in a substudy where eligible patients will undergo an additional procedure;cardiac magnetic resonance imaging.
- Being tested
- KAI-9803
- Keywords
- Heart Diseases, Myocardial Ischemia, Infarction, Myocardial Infarction
- Medical subject headings
- Myocardial Infarction, Cardiovascular Diseases, Pathologic Processes, Heart Diseases, Myocardial Ischemia, Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAI-9803Drug
STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
| Study group | Role | What they receive |
|---|---|---|
| A1: KAI-9803 | Experimental | Not described Receives: Drug: KAI-9803 |
| A2: KAI-9803 | Experimental | Not described Receives: Drug: KAI-9803 |
| A3: KAI-9803 | Experimental | Not described Receives: Drug: KAI-9803 |
| A4: Placebo | Placebo comparator | Not described Receives: Drug: KAI-9803 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of KAI-9803 on infarct size as assessed by CK-MB AUC
Measured: During the index hospitalization
Secondary outcomes (3)
The effect of KAI-9803 on the incidence of the composite of cardiovascular death, heart failure, or serious ventricular arrhythmias
Measured: Within the first 3 months after Myocardial Infarction
The safety and tolerability of KAI-9803 by IV infusion to acute STEMI
Measured: Within the first 3 months after Myocardial Infarction
Assess left ventricular function by imaging
Measured: Within the first 3 months after Myocardial Infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,180 participants (actual)
Sponsor and investigators
- Lead sponsor
- KAI Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb, The Cleveland Clinic, Duke University
- Responsible party
- Sponsor
- Investigators
- Gregory Bell, MD, Study director, KAI Pharmaceuticals, IncA.Michael Lincoff, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785954
- Sponsor's protocol ID
- KAI-9803-004
- Other IDs
- EudraCT: 2008-005140-16
- Acronym
- PROTECTION AMI
- Status last verified
- Aug 2011
- First submitted
- 3 Nov 2008
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lincoff AM, Roe M, Aylward P, Galla J, Rynkiewicz A, Guetta V, Zelizko M, Kleiman N, White H, McErlean E, Erlinge D, Laine M, Dos Santos Ferreira JM, Goodman S, Mehta S, Atar D, Suryapranata H, Jensen SE, Forster T, Fernandez-Ortiz A, Schoors D, Radke P, Belli G, Brennan D, Bell G, Krucoff M; PROTECTION AMI Investigators. Inhibition of delta-protein kinase C by delcasertib as an adjunct to primary percutaneous coronary intervention for acute anterior ST-segment elevation myocardial infarction: results of the PROTECTION AMI Randomized Controlled Trial. Eur Heart J. 2014 Oct 1;35(37):2516-23. doi: 10.1093/eurheartj/ehu177. Epub 2014 May 5.
PubMed 24796339
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibition of Delta-protein Kinase C for the Reduction of Infarct Size in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00785954
- Acronym / sponsor ID
- PROTECTION AMI / KAI-9803-004
- Keywords
- Heart Diseases, Myocardial Ischemia, Infarction, Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,180 participants (actual)
- Lead sponsor
- KAI PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb, The Cleveland Clinic, Duke University
- Study start
- Nov 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 5 Nov 2008 (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 purpose of this study is to determine whether KAI-9803 is safe and effective in reducing infarct size in subjects with ST elevation myocardial infarction (heart attack) undergoing a percutaneous coronary intervention (PCI). A select number of sites will also participate in a substudy where eligible patients will undergo an additional procedure;cardiac magnetic resonance imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1: KAI-9803 | Experimental | Drug: KAI-9803 |
| A2: KAI-9803 | Experimental | Drug: KAI-9803 |
| A3: KAI-9803 | Experimental | Drug: KAI-9803 |
| A4: Placebo | Placebo comparator | Drug: KAI-9803 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute STEMI and has a planned emergent primary PCI procedure
- Continuous symptoms of cardiac ischemia and present to the primary PCI facility within 6 hours of symptom onset
Key exclusion criteria (1 listed)
- Persistent systolic blood pressure < 90 mm Hg
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 |
|---|---|---|
| KAI-9803STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo | Drug | A1: KAI-9803, A2: KAI-9803, A3: KAI-9803, A4: Placebo |
Primary outcome
The effect of KAI-9803 on infarct size as assessed by CK-MB AUC
Time frame: During the index hospitalization
3 secondary outcomes
The effect of KAI-9803 on the incidence of the composite of cardiovascular death, heart failure, or serious ventricular arrhythmias
Time frame: Within the first 3 months after Myocardial Infarction
The safety and tolerability of KAI-9803 by IV infusion to acute STEMI
Time frame: Within the first 3 months after Myocardial Infarction
Assess left ventricular function by imaging
Time frame: Within the first 3 months after Myocardial Infarction
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 2 Sep 2011.
- Derived from this study: PubMed 24796339Lincoff AM, Roe M, Aylward P, Galla J, Rynkiewicz A, Guetta V, Zelizko M, Kleiman N, White H, McErlean E, Erlinge D, Laine M, Dos Santos Ferreira JM, Goodman S, Mehta S, Atar D, Suryapranata H, Jensen SE, Forster T, Fernandez-Ortiz A, Schoors D, Radke P, Belli G, Brennan D, Bell G, Krucoff M; PROTECTION AMI Investigators. Inhibition of delta-protein kinase C by delcasertib as an adjunct to primary percutaneous coronary intervention for acute anterior ST-segment elevation myocardial infarction: results of the PROTECTION AMI Randomized Controlled Trial. Eur Heart J. 2014 Oct 1;35(37):2516-23. doi: 10.1093/eurheartj/ehu177. Epub 2014 May 5.
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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.
Gregory Bell, MD study director
KAI Pharmaceuticals, Inc
A.Michael Lincoff, MD principal investigator
The Cleveland Clinic
126 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KAI-9803 in people with Myocardial Infarction and Cardiovascular Diseases, run by KAI Pharmaceuticals at 126 sites in 18 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 2 inclusion and 1 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 2 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 126 sites in United States, Australia, Poland, Canada, Czechia and 13 more countries. 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?
The effect of KAI-9803 on infarct size as assessed by CK-MB AUC (time frame: During the index hospitalization). 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 NCT00785954, which also lists 1 linked publication.
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 2 Sep 2011.