FRANCIS-ACS Trial: A Study of the Safety and Efficacy of A 002 in Subjects With Acute Coronary Syndromes
- Registration Number
- NCT00743925
- Lead Sponsor
- 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)
- 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 At that point, all active subjects (those who have not early withdrawn or those that have not already had a MACE) will be brought in for a Final Study Visit.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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 625
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Varespladib Methyl (A-002) A-002 (500 mg QD) plus Atorvastatin (80 mg QD) 2 Varespladib Methyl (A-002) Matching Placebo tablets plus Atorvastatin (80 mg QD)
- Primary Outcome Measures
Name Time Method Mean percent changes in LDL hs-CRP, sPLA2 and other biomarkers will be compared between the 2 treatment groups. 8 Weeks
- Secondary Outcome Measures
Name Time Method The occurrence of MACEs will be examined for any treatment-related trends at study completion. End of Study
Trial Locations
- Locations (37)
Cardiological hospital of The Patriarchate of all Georgia
🇬🇪Tbilisi, Georgia
Cardiological Clinic "Guli"
🇬🇪Tbilisi, Georgia
Department of Cardiology of Central Clinical Hospital
🇺🇦Kharkiv, Ukraine
New Hospital Medical Union
🇷🇺Ekaterinburg, Russian Federation
City Clinical Hospital №12
🇷🇺Nizhniy Novgorod, Russian Federation
Saint-Petersburg State Healthcare Institution
🇷🇺Saint-Petersburg, Russian Federation
Saratov State Medical University
🇷🇺Saratov, Russian Federation
State Institution Research Cardiology Institute
🇷🇺Tomsk, Russian Federation
Municipal Clinical Hospital No. 27
🇺🇦Kharkiv, Ukraine
Krasnoyarsk Medical Academy
🇷🇺Krasnoyarsk, Russian Federation
Cardio Reanimation Centre
🇬🇪Tbilisi, Georgia
Emergency Cardiology Center by acad. G. Chapidze
🇬🇪Tbilisi, Georgia
National Center of Therapy
🇬🇪Tbilisi, Georgia
Federal State Institution
🇷🇺Saratov, Russian Federation
L.T. Malaya Institute of Therapy of AMS of Ukraine
🇺🇦Kharkiv, Ukraine
National Scientific Center
🇺🇦Kyiv, Ukraine
State Healthcare Intstitution of Moscow
🇷🇺Moscow, Russian Federation
Tbilisi State Medical University, Al. Aladashvili University Clinic
🇬🇪Tbilisi, Georgia
Multiprofile Clinical Hospital of Tbilisi #2
🇬🇪Tbilisi, Georgia
Diagnostic Services Clinic
🇬🇪Tbilisi, Georgia
Limited Company "ADAPTI" The Clinic of Angiocardiology "ADAPTI"
🇬🇪Tbilisi, Georgia
Non-State Healthcare Institution
🇷🇺Kemerovo, Russian Federation
St.Petersburg State Healthcare Institution
🇷🇺St-Petersburg, Russian Federation
Federal State Healthcare Institution
🇷🇺St.Petersburg, Russian Federation
Tyumen Cardiology Center,
🇷🇺Tyumen, Russian Federation
Tbilisi LTD Cardiology Clinic
🇬🇪Tbilisi, Georgia
Municipal Healthcare Institution
🇷🇺Perm, Russian Federation
Regional State Healthcare Institution
🇷🇺Novosibirsk, Russian Federation
State Healthcare Institution
🇷🇺St-Petersburg, Russian Federation
State Educational Institution for Further Professional Training
🇷🇺St.Petersburg, Russian Federation
Kharkiv Medical Academy of Post-Graduate Education
🇺🇦Kharkiv, Ukraine
Kyiv City Clinical Hospital #1
🇺🇦Kyiv, Ukraine
Uzhgorod National University
🇺🇦Uzhgorod, Ukraine
Lviv Danylo Halytsky National University
🇺🇦Lviv, Ukraine
Lviv Regional State Clinical Treatment and Diagnostics Cardiology Center
🇺🇦Lviv, Ukraine
Zaporizhzhya Regional Cardiological Dispensary
🇺🇦Zaporizhzhya, Ukraine
Zhytomyr city hospital #1
🇺🇦Zhytomyr, Ukraine