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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00743925
First received: August 27, 2008
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Acute Coronary Syndrome
Drug: Varespladib Methyl (A-002)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Anthera Pharmaceuticals:

Primary Outcome Measures:
  • Mean percent changes in LDL hs-CRP, sPLA2 and other biomarkers will be compared between the 2 treatment groups. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The occurrence of MACEs will be examined for any treatment-related trends at study completion. [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Enrollment: 625
Study Start Date: July 2008
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743925

Locations
Georgia
National Center of Therapy
Tbilisi, Georgia, 0159
Tbilisi State Medical University, Al. Aladashvili University Clinic
Tbilisi, Georgia, 0102
Diagnostic Services Clinic
Tbilisi, Georgia, 0179
Cardio Reanimation Centre
Tbilisi, Georgia, 0141
Emergency Cardiology Center by acad. G. Chapidze
Tbilisi, Georgia, 0159
Tbilisi LTD Cardiology Clinic
Tbilisi, Georgia, 0144
Limited Company "ADAPTI" The Clinic of Angiocardiology "ADAPTI"
Tbilisi, Georgia, 0186
Cardiological hospital of The Patriarchate of all Georgia
Tbilisi, Georgia, 0102
Cardiological Clinic "Guli"
Tbilisi, Georgia, 0144
Multiprofile Clinical Hospital of Tbilisi #2
Tbilisi, Georgia, 0164
Russian Federation
New Hospital Medical Union
Ekaterinburg, Russian Federation, 620109
Municipal Healthcare Institution
Gatchina, Russian Federation, 188300
Non-State Healthcare Institution
Kemerovo, Russian Federation, 650055
Municipal Healthcare Institution
Kemerovo, Russian Federation, 650002
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
Regional State Healthcare Institution
Novosibirsk, Russian Federation, 630047
Municipal Healthcare Institution
Novosibirsk, Russian Federation, 630008
Municipal Healthcare Institution
Perm, Russian Federation, 614107
St.Petersburg State Healthcare Institution
Saint-Petersburg, Russian Federation, 191144
St.Petersburg State Healthcare Institution
Saint-Petersburg, Russian Federation, 190000
St.Petersburg State Healthcare Institution
Saint-Petersburg, Russian Federation, 199106
Saint-Petersburg State Healthcare Institution
Saint-Petersburg, Russian Federation, 198205
State Healthcare Institution
Samara, Russian Federation, 443070
Saratov State Medical University
Saratov, Russian Federation, 410012
Federal State Institution
Saratov, Russian Federation, 410028
St.Petersburg State Healthcare Institution
St-Petersburg, Russian Federation, 195257
State Healthcare Institution
St-Petersburg, Russian Federation, 195197
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
Ukraine
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
Municipal Clinical Hospital No. 27
Kharkiv, Ukraine, 61002
National Scientific Center
Kyiv, Ukraine, 03680
Kyiv City Clinical Hospital #1
Kyiv, Ukraine, 02175
Lviv Regional State Clinical Treatment and Diagnostics Cardiology Center
Lviv, Ukraine, 79015
Lviv Danylo Halytsky National University
Lviv, Ukraine, 79000
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
  More Information

Additional Information:
No publications provided

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00743925     History of Changes
Other Study ID Numbers: AN-CVD2224
Study First Received: August 27, 2008
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Anthera Pharmaceuticals:
Unstable Angina
STEMI
NSTEMI
ACS
Acute Coronary Syndrome
C14.280.647.124
C14.280.647.500

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Atorvastatin
Varespladib methyl
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Phospholipase A2 Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014