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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00743925
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : March 4, 2014
Information provided by (Responsible Party):
Anthera Pharmaceuticals

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Varespladib Methyl (A-002) Phase 2

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 At that point, all active subjects (those who have not early withdrawn or those that have not already had a MACE) will be brought in for a Final Study Visit.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  (Clinical Trial)
Actual Enrollment : 625 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: FRANCIS-ACS Trial: A Study of the Safety and Efficacy of A 002 in Subjects With Acute Coronary Syndromes
Study Start Date : July 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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:
  • A-002
  • Varespladib
  • Lipitor
  • Atorvastatin
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:
  • A-002
  • Varespladib
  • Lipitor
  • Atorvastatin

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

Secondary Outcome Measures :
  1. The occurrence of MACEs will be examined for any treatment-related trends at study completion. [ Time Frame: End of Study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00743925

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anthera Pharmaceuticals Identifier: NCT00743925     History of Changes
Other Study ID Numbers: AN-CVD2224
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: January 2014

Keywords provided by Anthera Pharmaceuticals:
Unstable Angina
Acute Coronary Syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin Calcium
Varespladib methyl
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Phospholipase A2 Inhibitors