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

NCT00743925 | Completed Phase 2

• 1 other identifier: AN-CVD2224
• Study Type: interventional
• Target: 625
• Locations: 3 countries
• Sites: 44

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)

Conditions

Acute Coronary Syndrome

Keywords

Unstable Angina; STEMI; NSTEMI; ACS; Acute Coronary Syndrome; C14.280.647.124; C14.280.647.500

Outcome Measures

Primary Outcomes (1)

• Mean percent changes in LDL hs-CRP, sPLA2 and other biomarkers will be compared between the 2 treatment groups.

  8 Weeks

Secondary Outcomes (1)

• The occurrence of MACEs will be examined for any treatment-related trends at study completion.

  End of Study

Study Arms (2)

1

ACTIVE COMPARATOR

A-002 (500 mg QD) plus Atorvastatin (80 mg QD)

Drug: Varespladib Methyl (A-002)

2

PLACEBO COMPARATOR

Matching Placebo tablets plus Atorvastatin (80 mg QD)

Drug: Varespladib Methyl (A-002)

Interventions

Varespladib Methyl (A-002) DRUG

2 Tablets (250 mg each) once daily for at least 24 weeks in combination with Atorvastatin (80 mg tablet once a day).

Also known as: A-002, Varespladib, Lipitor, Atorvastatin

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anthera Pharmaceuticals: lead

Study Sites (44)

Cardiological hospital of The Patriarchate of all Georgia

Tbilisi, 0102, Georgia

Location

Tbilisi State Medical University, Al. Aladashvili University Clinic

Tbilisi, 0102, Georgia

Location

Cardio Reanimation Centre

Tbilisi, 0141, Georgia

Location

Cardiological Clinic "Guli"

Tbilisi, 0144, Georgia

Location

Tbilisi LTD Cardiology Clinic

Tbilisi, 0144, Georgia

Location

Emergency Cardiology Center by acad. G. Chapidze

Tbilisi, 0159, Georgia

Location

National Center of Therapy

Tbilisi, 0159, Georgia

Location

Multiprofile Clinical Hospital of Tbilisi #2

Tbilisi, 0164, Georgia

Location

Diagnostic Services Clinic

Tbilisi, 0179, Georgia

Location

Limited Company "ADAPTI" The Clinic of Angiocardiology "ADAPTI"

Tbilisi, 0186, Georgia

Location

Municipal Healthcare Institution

Gatchina, 188300, Russia

Location

Municipal Healthcare Institution

Kemerovo, 650002, Russia

Location

Non-State Healthcare Institution

Kemerovo, 650055, Russia

Location

Krasnoyarsk Medical Academy

Krasnoyarsk, 660022, Russia

Location

State Healthcare Intstitution of Moscow

Moscow, 111539, Russia

Location

City Clinical Hospital №12

Nizhny Novgorod, 603003, Russia

Location

Municipal Healthcare Institution

Novosibirsk, 630008, Russia

Location

Regional State Healthcare Institution

Novosibirsk, 630047, Russia

Location

Municipal Healthcare Institution

Perm, 614107, Russia

Location

St.Petersburg State Healthcare Institution

Saint Petersburg, 190000, Russia

Location

State Educational Institution for Further Professional Training

Saint Petersburg, 191015, Russia

Location

St.Petersburg State Healthcare Institution

Saint Petersburg, 191144, Russia

Location

Federal State Healthcare Institution

Saint Petersburg, 194044, Russia

Location

State Healthcare Institution

Saint Petersburg, 195197, Russia

Location

St.Petersburg State Healthcare Institution

Saint Petersburg, 195257, Russia

Location

Saint-Petersburg State Healthcare Institution

Saint Petersburg, 198205, Russia

Location

St.Petersburg State Healthcare Institution

Saint Petersburg, 199106, Russia

Location

State Healthcare Institution

Samara, 443070, Russia

Location

Saratov State Medical University

Saratov, 410012, Russia

Location

Federal State Institution

Saratov, 410028, Russia

Location

State Institution Research Cardiology Institute

Tomsk, 634012, Russia

Location

Tyumen Cardiology Center,

Tyumen, 625026, Russia

Location

New Hospital Medical Union

Yekaterinburg, 620109, Russia

Location

Municipal Clinical Hospital No. 27

Kharkiv, 61002, Ukraine

Location

Department of Cardiology of Central Clinical Hospital

Kharkiv, 61018, Ukraine

Location

L.T. Malaya Institute of Therapy of AMS of Ukraine

Kharkiv, 61039, Ukraine

Location

Kharkiv Medical Academy of Post-Graduate Education

Kharkiv, 61178, Ukraine

Location

Kyiv City Clinical Hospital #1

Kyiv, 02175, Ukraine

Location

National Scientific Center

Kyiv, 03680, Ukraine

Location

Lviv Danylo Halytsky National University

Lviv, 79000, Ukraine

Location

Lviv Regional State Clinical Treatment and Diagnostics Cardiology Center

Lviv, 79015, Ukraine

Location

Uzhgorod National University

Uzhhorod, 88014, Ukraine

Location

Zaporizhzhya Regional Cardiological Dispensary

Zaporizhzhya, 69000, Ukraine

Location

Zhytomyr city hospital #1

Zhytomyr, 10002, Ukraine

Location

Related Publications (1)

• Rosenson RS, Hislop C, Elliott M, Stasiv Y, Goulder M, Waters D. Effects of varespladib methyl on biomarkers and major cardiovascular events in acute coronary syndrome patients. J Am Coll Cardiol. 2010 Sep 28;56(14):1079-88. doi: 10.1016/j.jacc.2010.06.015.

  PMID: 20863951 DERIVED

Related Links

• Sponsor's Website

MeSH Terms

Conditions

Acute Coronary Syndrome; Angina, Unstable; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Interventions

varespladib methyl; varespladib; Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 29, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: April 1, 2010
• Last Updated: March 4, 2014

Record last verified: 2014-01

Locations

GE (10); UA (11); RU (23)