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Acute Coronary SyndromePhase 2CHI SQUARENCT01201837

Effect of CER-001 on Atherosclerosis in Acute Coronary Syndrome (ACS) Patients - Efficacy and Safety: The CHI SQUARE Trial

A Phase 2 study testing CER-001 in people with Acute Coronary Syndrome, run by Cerenis Therapeutics, SA at 47 sites in 4 countries.

Completed

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

Official record
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Trial summary

Cardiovascular disease remains the most pressing healthcare issue for developed countries and is becoming so for developing countries. There are a number of chronic therapies available for long-term management of risk. Read more about this study

Who is it for?
Ages Up to 75 years
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
CER-001
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
507 participants
Where
47 sitesin 4 countries
Study dates
Mar 2011to Mar 2013
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 Up to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or female less than 75 years of age
  • Acute coronary syndrome (acute chest pain and a diagnosis of ST segment elevation myocardial infarction, non-ST elevation myocardial infarction or unstable angina)
  • Angiographic evidence of coronary artery disease with suitable "target" coronary artery for IVUS evaluation

Who cannot join

  • Females of child-bearing potential
  • Weight >120 kg
  • Angiographic evidence of >50% stenosis of the left main artery
  • Uncontrolled diabetes (HbA1C>10%)
  • Hypertriglyceridemia (>500 mg/dL)
  • Congestive heart failure (NYHA class III or IV)
Show all 9Show fewer
  • Ejection fraction <35%
  • Uncontrolled hypertension (SBP >180 mm Hg)
  • Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction

Trial locations and contacts

47 sites in 4 countries.

47 sites in 4 countries

United States24 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Saint Joseph Research Institute

    Atlanta, Georgia, 30342

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • Palm Beach Heart Institute, LLC - Zasa Clinical Research

    Boynton Beach, Florida, 33472

  • Buffalo Heart Group

    Buffalo, New York, 14215

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27599

  • Heart and Vascular Institute of Florida

    Clearwater, Florida, 33755

  • Dallas VA Medical Center

    Dallas, Texas, 75016

  • Detroit Medical Center (DMC) Cardiovascular Institute

    Detroit, Michigan, 48201

  • Sanford Heart Center

    Fargo, North Dakota, 58122

  • LeBauer Cardiovascular Research Foundation

    Greensboro, North Carolina, 27401

  • Heart Center Research LLC

    Huntsville, Alabama, 35801

  • The Care Group, LLC

    Indianapolis, Indiana, 46260

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

  • South Oklahoma Heart Research

    Oklahoma City, Oklahoma, 73135

  • Alegent Research Center

    Omaha, Nebraska, 68124

  • Cardiac and Vascular Research Center of Northern Michigan

    Petoskey, Michigan, 49770

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic - Arizona

    Phoenix, Arizona, 85054

  • VA San Diego Health Care Center

    San Diego, California, 92161

  • Sanford Research / USD

    Sioux Falls, South Dakota, 57104

  • MultiCare Health System Research Institute / Cardiac Study Center

    Tacoma, Washington, 98405

  • Buffalo Cardiology & Pulmonary Associates

    Williamsville, New York, 14221

Other trials in United States

Canada11 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • Centre de Santé et de Services Sociaux de Laval

    Laval, Quebec, H7M 3L9

  • London Health Sciences Center

    London, Ontario, N6A 5A5

  • Montreal Heart Institute

    Montreal, Quebec, H1T1C8

  • Montreal General Hospital Research Institute

    Montreal, Quebec, H3G 1A4

  • Institut Universitaire de Cardiologie et Pneumologie de Québec (IUCPQ)

    Québec, Quebec, G1V 4G5

  • CSSS du Nord de Lanaudière

    Saint-Charles-Borromée, Quebec, J6E 6J2

  • St. John Health Center

    St. John's, Newfoundland and Labrador, A1B 3V6

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Centre Hospitalier Régional de Trois-Rivières

    Trois-Rivières, Quebec, G8Z 3R9

  • Victoria Heart Institute Foundation

    Victoria, British Columbia, V8R 4R2

Other trials in Canada

Netherlands9 sites

  • Medisch Centrum Alkmaar

    Alkmaar, Amsterdam, JD 1815

  • Onze Lieve Vrouwe Gasthius

    Amsterdam, AC, 1091

  • Academic Medical Center

    Amsterdam, AZ, 1105

  • Catharina Ziekenhuis Eindhoven

    Eindhoven, EJ, 5623

  • Medisch Spectrum Twente

    Enschede, ER, 7513

  • Medisch Centrum Leeuwarden

    Leeuwarden, AD, 8934

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, CM, 3430

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen, SZ, 6532

  • Maassstadziekenhuis Cardiology Research

    Rotterdam, DZ, 3079

Other trials in Netherlands

France3 sites

  • Hôpital Cardiologique du Haut-Lévesque

    Bordeaux, Pessac Cedex, 33064

  • Clinique Pasteur

    Toulouse, 31076

  • Centre Hospitalier Universitaire de Toulouse Rangueil

    Toulouse

Other trials in France

About this study

Official title: CHI SQUARE: Can HDL Infusions Significantly Quicken Atherosclerosis Regression? A Phase II, Multi-Center, Double-Blind, Ascending Dose, Placebo-Controlled, Dose-Finding Trial of CER-001 or Placebo in Subjects With Acute Coronary Syndrome

Cardiovascular disease remains the most pressing healthcare issue for developed countries and is becoming so for developing countries. There are a number of chronic therapies available for long-term management of risk. Short term therapies for subjects with an acute event, such as an episode of acute coronary syndrome (ACS), are focused on reperfusion and removing thrombus but most subsequent events are caused by atherosclerotic plaque rupture at a different site. There are no approved therapies that can rapidly reduce the burden of unstable, inflamed plaque in the overall coronary vascular bed. HDL has multiple actions that could lead to atherosclerotic plaque stabilization, such as rapid removal of large quantities of cholesterol from the vasculature, improvement in endothelial function, protection against oxidative damage and reduction in inflammation. This study will assess the effects of CER-001, an ApoA-I-based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by intravascular ultrasound (IVUS) measurements in patients with (ACS).

Being tested
Placebo, CER-001
Keywords
Acute coronary syndrome, HDL mimetic, ApoA-I
Medical subject headings
Acute Coronary Syndrome

What participants receive

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

  • PlaceboDrug

    Weekly injection

  • CER-001Drug

    Weekly injection

Study groups in NCT01201837
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Low DoseExperimentalCER-001 Low Dose
Receives: Drug: CER-001
Mid DoseExperimentalCER-001 Mid Dose
Receives: Drug: CER-001
High DoseExperimentalCER-001 High Dose
Receives: Drug: CER-001

What is being measured

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

  1. Change in Total Plaque Volume

    Absolute change in total plaque volume, as assessed by IVUS, from the baseline measurement to the follow-up taken ~3 weeks following the final dose of study medication (approximately 9 weeks after the baseline assessment)

    Measured: Baseline and 3 weeks post final dose

Secondary outcomes (1)

  1. Percent Change in Plaque Volume

    Percent change in total plaque volume, as assessed by IVUS, from the baseline measurement to the follow-up taken ~3 weeks following the final dose of study medication (approximately 9 weeks after the baseline assessment)

    Measured: Baseline and 3 weeks post final dose

Timeline

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

  1. First posted15 Sep 2010 (estimated)
  2. Study startMar 2011
  3. Primary completionOct 2012
  4. Study completionMar 2013

Resources

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
507 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01201837
Sponsor's protocol ID
CER-001-CLIN-002
Acronym
CHI SQUARE
Status last verified
Jan 2014
First submitted
13 Sep 2010
Last updated
3 Mar 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Nanjee MN, Doran JE, Lerch PG, Miller NE. Acute effects of intravenous infusion of ApoA1/phosphatidylcholine discs on plasma lipoproteins in humans. Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):979-89. doi: 10.1161/01.atv.19.4.979.

    PubMed 10195926

  • Eriksson M, Carlson LA, Miettinen TA, Angelin B. Stimulation of fecal steroid excretion after infusion of recombinant proapolipoprotein A-I. Potential reverse cholesterol transport in humans. Circulation. 1999 Aug 10;100(6):594-8. doi: 10.1161/01.cir.100.6.594.

    PubMed 10441095

  • Spieker LE, Sudano I, Hurlimann D, Lerch PG, Lang MG, Binggeli C, Corti R, Ruschitzka F, Luscher TF, Noll G. High-density lipoprotein restores endothelial function in hypercholesterolemic men. Circulation. 2002 Mar 26;105(12):1399-402. doi: 10.1161/01.cir.0000013424.28206.8f.

    PubMed 11914243

  • Nieuwdorp M, Vergeer M, Bisoendial RJ, op 't Roodt J, Levels H, Birjmohun RS, Kuivenhoven JA, Basser R, Rabelink TJ, Kastelein JJ, Stroes ES. Reconstituted HDL infusion restores endothelial function in patients with type 2 diabetes mellitus. Diabetologia. 2008 Jun;51(6):1081-4. doi: 10.1007/s00125-008-0975-2. Epub 2008 Apr 4. No abstract available.

    PubMed 18389214

  • Drew BG, Duffy SJ, Formosa MF, Natoli AK, Henstridge DC, Penfold SA, Thomas WG, Mukhamedova N, de Courten B, Forbes JM, Yap FY, Kaye DM, van Hall G, Febbraio MA, Kemp BE, Sviridov D, Steinberg GR, Kingwell BA. High-density lipoprotein modulates glucose metabolism in patients with type 2 diabetes mellitus. Circulation. 2009 Apr 21;119(15):2103-11. doi: 10.1161/CIRCULATIONAHA.108.843219. Epub 2009 Apr 6.

    PubMed 19349317

  • Shaw JA, Bobik A, Murphy A, Kanellakis P, Blombery P, Mukhamedova N, Woollard K, Lyon S, Sviridov D, Dart AM. Infusion of reconstituted high-density lipoprotein leads to acute changes in human atherosclerotic plaque. Circ Res. 2008 Nov 7;103(10):1084-91. doi: 10.1161/CIRCRESAHA.108.182063. Epub 2008 Oct 2.

    PubMed 18832751

  • Waksman R, Torguson R, Kent KM, Pichard AD, Suddath WO, Satler LF, Martin BD, Perlman TJ, Maltais JA, Weissman NJ, Fitzgerald PJ, Brewer HB Jr. A first-in-man, randomized, placebo-controlled study to evaluate the safety and feasibility of autologous delipidated high-density lipoprotein plasma infusions in patients with acute coronary syndrome. J Am Coll Cardiol. 2010 Jun 15;55(24):2727-35. doi: 10.1016/j.jacc.2009.12.067.

    PubMed 20538165

  • Tardif JC, Gregoire J, L'Allier PL, Ibrahim R, Lesperance J, Heinonen TM, Kouz S, Berry C, Basser R, Lavoie MA, Guertin MC, Rodes-Cabau J; Effect of rHDL on Atherosclerosis-Safety and Efficacy (ERASE) Investigators. Effects of reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized controlled trial. JAMA. 2007 Apr 18;297(15):1675-82. doi: 10.1001/jama.297.15.jpc70004. Epub 2007 Mar 26.

    PubMed 17387133

  • Nissen SE, Tsunoda T, Tuzcu EM, Schoenhagen P, Cooper CJ, Yasin M, Eaton GM, Lauer MA, Sheldon WS, Grines CL, Halpern S, Crowe T, Blankenship JC, Kerensky R. Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial. JAMA. 2003 Nov 5;290(17):2292-300. doi: 10.1001/jama.290.17.2292.

    PubMed 14600188

  • Tardif JC, Ballantyne CM, Barter P, Dasseux JL, Fayad ZA, Guertin MC, Kastelein JJ, Keyserling C, Klepp H, Koenig W, L'Allier PL, Lesperance J, Luscher TF, Paolini JF, Tawakol A, Waters DD; Can HDL Infusions Significantly QUicken Atherosclerosis REgression (CHI-SQUARE) Investigators. Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial. Eur Heart J. 2014 Dec 7;35(46):3277-86. doi: 10.1093/eurheartj/ehu171. Epub 2014 Apr 29.

    PubMed 24780501

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CER-001 in people with Acute Coronary Syndrome, run by Cerenis Therapeutics, SA at 47 sites in 4 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 3 inclusion and 9 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 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Canada, Netherlands, France. 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?

Change in Total Plaque Volume (time frame: Baseline and 3 weeks post final dose). 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 NCT01201837, which also lists 10 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 3 Mar 2014.

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