FRANCIS-ACS Trial: A Study of the Safety and Efficacy of A 002 in Subjects With Acute Coronary Syndromes (FRANCIS-ACS)

January 30, 2014 updated by: Anthera Pharmaceuticals
The objective of this study is to evaluate the safety and efficacy of A 002 when added to high dose atorvastatin in subjects with an acute coronary syndrome (ACS)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind randomized parallel group placebo controlled study in subjects presenting with an ACS. Subjects will be randomized to receive either A 002 500 mg once daily (QD) or placebo tablets in addition to 80 mg atorvastatin QD.

Randomization must occur within ≤96 hours of hospital admission for the index ACS event, or, if already hospitalized, within ≤96 hours of index event diagnosis. Follow-up visits will occur at Weeks 2, 4, 8, 12, 16, 20, and 24 post-randomization; and monthly thereafter until study completion.

All enrolled subjects will remain on treatment until all subjects have been treated for a minimum of 24 weeks or until the occurrence of a Major Adverse Cardiac Event (MACE). At that point, all active subjects (those who have not early withdrawn or those that have not already had a MACE) will be brought in for a Final Study Visit. Subjects who complete the Final Study Visit may be eligible to enroll in an open-label extension study for up to 2 years total study drug exposure.

Study Type

Interventional

Enrollment (Actual)

625

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Georgia
      • Tbilisi, Georgia, 0159
        • National Center of Therapy
      • Tbilisi, Georgia, 0179
        • Diagnostic Services Clinic
      • Tbilisi, Georgia, 0164
        • Multiprofile Clinical Hospital of Tbilisi #2
      • Tbilisi, Georgia, 0102
        • Cardiological hospital of The Patriarchate of all Georgia
      • Tbilisi, Georgia, 0102
        • Tbilisi State Medical University, Al. Aladashvili University Clinic
      • Tbilisi, Georgia, 0141
        • Cardio Reanimation Centre
      • Tbilisi, Georgia, 0144
        • Cardiological Clinic "Guli"
      • Tbilisi, Georgia, 0144
        • Tbilisi LTD Cardiology Clinic
      • Tbilisi, Georgia, 0159
        • Emergency Cardiology Center by acad. G. Chapidze
      • Tbilisi, Georgia, 0186
        • Limited Company "ADAPTI" The Clinic of Angiocardiology "ADAPTI"
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620109
        • New Hospital Medical Union
      • Gatchina, Russian Federation, 188300
        • Municipal Healthcare Institution
      • Kemerovo, Russian Federation, 650002
        • Municipal Healthcare Institution
      • Kemerovo, Russian Federation, 650055
        • Non-State Healthcare Institution
      • Krasnoyarsk, Russian Federation, 660022
        • Krasnoyarsk Medical Academy
      • Moscow, Russian Federation, 111539
        • State Healthcare Intstitution of Moscow
      • Nizhniy Novgorod, Russian Federation, 603003
        • City Clinical Hospital №12
      • Novosibirsk, Russian Federation, 630008
        • Municipal Healthcare Institution
      • Novosibirsk, Russian Federation, 630047
        • Regional State Healthcare Institution
      • Perm, Russian Federation, 614107
        • Municipal Healthcare Institution
      • Saint-Petersburg, Russian Federation, 190000
        • St.Petersburg State Healthcare Institution
      • Saint-Petersburg, Russian Federation, 191144
        • St.Petersburg State Healthcare Institution
      • Saint-Petersburg, Russian Federation, 198205
        • Saint-Petersburg State Healthcare Institution
      • Saint-Petersburg, Russian Federation, 199106
        • St.Petersburg State Healthcare Institution
      • Samara, Russian Federation, 443070
        • State Healthcare Institution
      • Saratov, Russian Federation, 410012
        • Saratov State Medical University
      • Saratov, Russian Federation, 410028
        • Federal State Institution
      • St-Petersburg, Russian Federation, 195197
        • State Healthcare Institution
      • St-Petersburg, Russian Federation, 195257
        • St.Petersburg State Healthcare Institution
      • St.Petersburg, Russian Federation, 191015
        • State Educational Institution for Further Professional Training
      • St.Petersburg, Russian Federation, 194044
        • Federal State Healthcare Institution
      • Tomsk, Russian Federation, 634012
        • State Institution Research Cardiology Institute
      • Tyumen, Russian Federation, 625026
        • Tyumen Cardiology Center,
  • Ukraine
      • Kharkiv, Ukraine, 61002
        • Municipal Clinical Hospital No. 27
      • Kharkiv, Ukraine, 61018
        • Department of Cardiology of Central Clinical Hospital
      • Kharkiv, Ukraine, 61039
        • L.T. Malaya Institute of Therapy of AMS of Ukraine
      • Kharkiv, Ukraine, 61178
        • Kharkiv Medical Academy of Post-Graduate Education
      • Kyiv, Ukraine, 02175
        • Kyiv City Clinical Hospital #1
      • Kyiv, Ukraine, 03680
        • National Scientific Center
      • Lviv, Ukraine, 79000
        • Lviv Danylo Halytsky National University
      • Lviv, Ukraine, 79015
        • Lviv Regional State Clinical Treatment and Diagnostics Cardiology Center
      • Uzhgorod, Ukraine, 88014
        • Uzhgorod National University
      • Zaporizhzhya, Ukraine, 69000
        • Zaporizhzhya Regional Cardiological Dispensary
      • Zhytomyr, Ukraine, 10002
        • Zhytomyr city hospital #1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women ≥18 years of age
  • A diagnosis of unstable angina, NSTEMI, or STEMI
  • Any one of the following criteria: Diabetes, CRP ≥2 mg/L, or metabolic syndrome
  • Subjects must be randomized within 96 hours of the index event
  • Percutaneous revascularization, if required or planned, must occur prior to randomization

Exclusion Criteria:

- Subjects must NOT meet any of the following exclusion criteria:

  • Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to Screening.
  • Subjects treated for cancer within the previous 5 years except for skin basal cell carcinoma or carcinoma in situ of the cervix, with measures other than a minor, complete surgical excision (e.g., chemotherapy), or radiation therapy.
  • The presence of severe liver disease with cirrhosis, recent active hepatitis, active chronic hepatitis, ALT or AST >3 x ULN, biliary obstruction with hyperbilirubinemia (total bilirubin >2 x ULN)
  • Active cholecystitis, gall bladder symptoms, or potential hepato-biliary abnormalities
  • The presence of severe renal impairment (CrCl <30 mL/min or creatinine >3 x ULN), nephrotic syndrome, or patients undergoing dialysis
  • Uncontrolled diabetes mellitus (HbA1c >11% within the last 1 month prior to Screening)
  • Females who are nursing, pregnant, or intend to become pregnant during the time of the study, or females of child-bearing potential who have a positive pregnancy test during screening evaluation. Women of child-bearing potential must also use a reliable method of birth control during the study and for 1 month following completion of therapy. A reliable method for this study is defined as one of the following: oral or injectable contraceptives, IUD, contraceptive implants, tubal ligation, hysterectomy, a barrier method (diaphragm with spermicidal foam or jelly, or a condom).
  • Subjects who have a history of alcohol or drug abuse within 1 year of study entry
  • Subjects living too far from participating center or unable to return for follow-up visits
  • Subjects who in the opinion of the Investigator are a poor medical or psychiatric risk for therapy with an investigational drug, are unreliable, or have an incomplete understanding of the study which may affect their ability to take drugs as prescribed or comply with instructions
  • Known HIV, Hepatitis B or C virus, or tuberculosis infection
  • Acute bacterial, fungal or viral infection
  • Any current statin therapy at maximum recommended dosage. For atorvastatin, fluvastatin, lovastatin, pravastatin and simvastatin 80 mg QD at the time of the index event and for rosuvastatin 20 mg QD to 40 mg QD
  • Drugs that are potent inhibitors of cytochrome P450 unless they can be withdrawn
  • Subjects with NYHA Class III or IV heart failure, or LVEF <30
  • Subjects with moderate or severe aortic stenosis, aortic regurgitation, mitral stenosis or mitral regurgitation
  • Ventricular arrhythmias requiring chronic drug treatment or ICD
  • Subjects with no stenosis or stenosis <50% on angiography
  • Subjects with a pacemaker or persistent LBBB
  • LDL-C >200 mg/dL (5.2 mmol/L)
  • Fasting triglyceride levels of ≥400 mg/dL (4.5 mmol/L)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
A-002 (500 mg QD) plus Atorvastatin (80 mg QD)
Drug: Varespladib Methyl (A-002)
2 Tablets (250 mg each) once daily for at least 24 weeks in combination with Atorvastatin (80 mg tablet once a day).
Other Names:
  • Lipitor
  • Atorvastatin
  • A-002
  • Varespladib
Placebo Comparator: 2
Matching Placebo tablets plus Atorvastatin (80 mg QD)
Drug: Varespladib Methyl (A-002)
2 Tablets (250 mg each) once daily for at least 24 weeks in combination with Atorvastatin (80 mg tablet once a day).
Other Names:
  • Lipitor
  • Atorvastatin
  • A-002
  • Varespladib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean percent changes in LDL hs-CRP, sPLA2 and other biomarkers will be compared between the 2 treatment groups.
Time Frame: 8 Weeks
8 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The occurrence of MACEs will be examined for any treatment-related trends at study completion.
Time Frame: End of Study
End of Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthera Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (Estimate)

August 29, 2008

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-CVD2224

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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