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

Acute Coronary Syndrome Clinical Trial

— FRANCIS-ACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743925
• Other study ID #: AN-CVD2224
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2008
• Last updated: January 30, 2014
• Start date: July 2008
• Est. completion date: April 2010

Study information

• Verified date: January 2014
• Source: Anthera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

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 At that point, all active subjects (those who have not early withdrawn or those that have not already had a MACE) will be brought in for a Final Study Visit.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 information / eligibility

• Status: Completed
• Enrollment: 625
• Est. completion date: April 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

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).

Locations

Country	Name	City	State
Georgia	Cardio Reanimation Centre	Tbilisi
Georgia	Cardiological Clinic "Guli"	Tbilisi
Georgia	Cardiological hospital of The Patriarchate of all Georgia	Tbilisi
Georgia	Diagnostic Services Clinic	Tbilisi
Georgia	Emergency Cardiology Center by acad. G. Chapidze	Tbilisi
Georgia	Limited Company "ADAPTI" The Clinic of Angiocardiology "ADAPTI"	Tbilisi
Georgia	Multiprofile Clinical Hospital of Tbilisi #2	Tbilisi
Georgia	National Center of Therapy	Tbilisi
Georgia	Tbilisi LTD Cardiology Clinic	Tbilisi
Georgia	Tbilisi State Medical University, Al. Aladashvili University Clinic	Tbilisi
Russian Federation	New Hospital Medical Union	Ekaterinburg
Russian Federation	Municipal Healthcare Institution	Gatchina
Russian Federation	Municipal Healthcare Institution	Kemerovo
Russian Federation	Non-State Healthcare Institution	Kemerovo
Russian Federation	Krasnoyarsk Medical Academy	Krasnoyarsk
Russian Federation	State Healthcare Intstitution of Moscow	Moscow
Russian Federation	City Clinical Hospital ?12	Nizhniy Novgorod
Russian Federation	Municipal Healthcare Institution	Novosibirsk
Russian Federation	Regional State Healthcare Institution	Novosibirsk
Russian Federation	Municipal Healthcare Institution	Perm
Russian Federation	Saint-Petersburg State Healthcare Institution	Saint-Petersburg
Russian Federation	St.Petersburg State Healthcare Institution	Saint-Petersburg
Russian Federation	St.Petersburg State Healthcare Institution	Saint-Petersburg
Russian Federation	St.Petersburg State Healthcare Institution	Saint-Petersburg
Russian Federation	State Healthcare Institution	Samara
Russian Federation	Federal State Institution	Saratov
Russian Federation	Saratov State Medical University	Saratov
Russian Federation	St.Petersburg State Healthcare Institution	St-Petersburg
Russian Federation	State Healthcare Institution	St-Petersburg
Russian Federation	Federal State Healthcare Institution	St.Petersburg
Russian Federation	State Educational Institution for Further Professional Training	St.Petersburg
Russian Federation	State Institution Research Cardiology Institute	Tomsk
Russian Federation	Tyumen Cardiology Center,	Tyumen
Ukraine	Department of Cardiology of Central Clinical Hospital	Kharkiv
Ukraine	Kharkiv Medical Academy of Post-Graduate Education	Kharkiv
Ukraine	L.T. Malaya Institute of Therapy of AMS of Ukraine	Kharkiv
Ukraine	Municipal Clinical Hospital No. 27	Kharkiv
Ukraine	Kyiv City Clinical Hospital #1	Kyiv
Ukraine	National Scientific Center	Kyiv
Ukraine	Lviv Danylo Halytsky National University	Lviv
Ukraine	Lviv Regional State Clinical Treatment and Diagnostics Cardiology Center	Lviv
Ukraine	Uzhgorod National University	Uzhgorod
Ukraine	Zaporizhzhya Regional Cardiological Dispensary	Zaporizhzhya
Ukraine	Zhytomyr city hospital #1	Zhytomyr

Sponsors (1)

Lead Sponsor	Collaborator
Anthera Pharmaceuticals

Countries where clinical trial is conducted

Georgia,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percent changes in LDL hs-CRP, sPLA2 and other biomarkers will be compared between the 2 treatment groups.		8 Weeks	No
Secondary	The occurrence of MACEs will be examined for any treatment-related trends at study completion.		End of Study	No

External Links

•   Sponsor's Website