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Acute Coronary SyndromePhase 2FRANCIS-ACSNCT00743925

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

A Phase 2 study testing Varespladib Methyl (A-002) in people with Acute Coronary Syndrome, run by Anthera Pharmaceuticals at 44 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Varespladib Methyl (A-002)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
625 participants
Where
44 sitesin 3 countries
Study dates
Jul 2008to Apr 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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)

Trial locations and contacts

44 sites in 3 countries.

44 sites in 3 countries

Russia23 sites

  • Municipal Healthcare Institution

    Gatchina, 188300

  • Municipal Healthcare Institution

    Kemerovo, 650002

  • Non-State Healthcare Institution

    Kemerovo, 650055

  • Krasnoyarsk Medical Academy

    Krasnoyarsk, 660022

  • State Healthcare Intstitution of Moscow

    Moscow, 111539

  • City Clinical Hospital №12

    Nizhny Novgorod, 603003

  • Municipal Healthcare Institution

    Novosibirsk, 630008

  • Regional State Healthcare Institution

    Novosibirsk, 630047

  • Municipal Healthcare Institution

    Perm, 614107

  • St.Petersburg State Healthcare Institution

    Saint Petersburg, 190000

  • State Educational Institution for Further Professional Training

    Saint Petersburg, 191015

  • St.Petersburg State Healthcare Institution

    Saint Petersburg, 191144

  • Federal State Healthcare Institution

    Saint Petersburg, 194044

  • State Healthcare Institution

    Saint Petersburg, 195197

  • St.Petersburg State Healthcare Institution

    Saint Petersburg, 195257

  • Saint-Petersburg State Healthcare Institution

    Saint Petersburg, 198205

  • St.Petersburg State Healthcare Institution

    Saint Petersburg, 199106

  • State Healthcare Institution

    Samara, 443070

  • Saratov State Medical University

    Saratov, 410012

  • Federal State Institution

    Saratov, 410028

  • State Institution Research Cardiology Institute

    Tomsk, 634012

  • Tyumen Cardiology Center,

    Tyumen, 625026

  • New Hospital Medical Union

    Yekaterinburg, 620109

Other trials in Russia

Ukraine11 sites

  • Municipal Clinical Hospital No. 27

    Kharkiv, 61002

  • Department of Cardiology of Central Clinical Hospital

    Kharkiv, 61018

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

    Kharkiv, 61039

  • Kharkiv Medical Academy of Post-Graduate Education

    Kharkiv, 61178

  • Kyiv City Clinical Hospital #1

    Kyiv, 02175

  • National Scientific Center

    Kyiv, 03680

  • Lviv Danylo Halytsky National University

    Lviv, 79000

  • Lviv Regional State Clinical Treatment and Diagnostics Cardiology Center

    Lviv, 79015

  • Uzhgorod National University

    Uzhhorod, 88014

  • Zaporizhzhya Regional Cardiological Dispensary

    Zaporizhzhya, 69000

  • Zhytomyr city hospital #1

    Zhytomyr, 10002

Other trials in Ukraine

Georgia10 sites

  • Cardiological hospital of The Patriarchate of all Georgia

    Tbilisi, 0102

  • Tbilisi State Medical University, Al. Aladashvili University Clinic

    Tbilisi, 0102

  • Cardio Reanimation Centre

    Tbilisi, 0141

  • Cardiological Clinic "Guli"

    Tbilisi, 0144

  • Tbilisi LTD Cardiology Clinic

    Tbilisi, 0144

  • Emergency Cardiology Center by acad. G. Chapidze

    Tbilisi, 0159

  • National Center of Therapy

    Tbilisi, 0159

  • Multiprofile Clinical Hospital of Tbilisi #2

    Tbilisi, 0164

  • Diagnostic Services Clinic

    Tbilisi, 0179

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

    Tbilisi, 0186

Other trials in Georgia

About this study

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)

Read the 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.

Being tested
Varespladib Methyl (A-002)
Keywords
Unstable Angina, STEMI, NSTEMI, ACS, Acute Coronary Syndrome, C14.280.647.124, C14.280.647.500
Medical subject headings
Acute Coronary Syndrome, Angina, Unstable, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Varespladib Methyl (A-002)Drug

    Also called A-002, Varespladib, Lipitor, Atorvastatin

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

Study groups in NCT00743925
Study groupRoleWhat they receive
1Active comparatorA-002 (500 mg QD) plus Atorvastatin (80 mg QD)
Receives: Drug: Varespladib Methyl (A-002)
2Placebo comparatorMatching Placebo tablets plus Atorvastatin (80 mg QD)
Receives: Drug: Varespladib Methyl (A-002)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 8 Weeks

Secondary outcomes (1)

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

    Measured: End of Study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJan 2010
  4. Study completionApr 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
625 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00743925
Sponsor's protocol ID
AN-CVD2224
Acronym
FRANCIS-ACS
Status last verified
Jan 2014
First submitted
27 Aug 2008
Last updated
4 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20863951

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Varespladib Methyl (A-002) in people with Acute Coronary Syndrome, run by Anthera Pharmaceuticals at 44 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Russia, Ukraine, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean percent changes in LDL hs-CRP, sPLA2 and other biomarkers will be compared between the 2 treatment groups. (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00743925, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.

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