Atrial FibrillationPhase 2NCT03398434
Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation
A Phase 2 study testing MAA868 and Apixaban in people with Atrial Fibrillation, run by Novartis Pharmaceuticals.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- MAA868 and Apixaban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Oct 2018to 30 Jan 2020
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients ≥ 55 and < 85 years old
- Body weight between 50 and 130 kg inclusive
- Atrial fibrillation or atrial flutter, as documented by electrocardiography
- CHA2DS2-VASc risk score ≥ 2 for male and female patients. Male patients with CHA2DS2VASc risk score of 1 can be included if anticoagulation therapy is warranted.
- Either anticoagulant-naïve or receiving a stable treatment of a recommended dose of a new oral anticoagulant (NOAC) over the 8 weeks prior to screening.
Who cannot join
- History of stroke, transient ischemic attack or systemic embolism
- History of major bleeding during treatment with an anticoagulant or antiplatelet therapy in the last 12 months
- History of traumatic or non-traumatic intracranial, intraspinal or intra-ocular bleeding
- Known bleeding diathesis or any known active bleeding site at screening or baseline
- Family history of bleeding disorder
- Known active GI lesions predisposing to bleeding events
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- Myocardial infarction, unstable angina pectoris or coronary artery bypass graft (CABG) surgery within 12 months prior to the screening period
- Known hemodynamically significant valvular heart disease
- Uncontrolled hypertension defined as SBP/DBP ≥ 160/100 mmHg at the screening visit
- Heart failure NYHA class IV in the 3 months prior to the screening visit
- Dual antiplatelet therapy. Treatment with a P2Y12 inhibitor or low dose aspirin (≤ 100 mg/d) is allowed but not both.
- Severe renal impairment (creatinine clearance < 30 mL/min) at the screening visit
About this study
Official title: A Multicenter, Randomized, Open-label, Active-controlled, Dose-range Finding Study to Assess the Pharmacodynamic Parameters, Safety and Tolerability of MAA868 and Its Effect on Thrombogenesis Biomarkers Compared to Apixaban in Patients With Atrial Fibrillation
The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- MAA868, Apixaban
- Keywords
- MAA868, apixaban, atrial fibrillation, anticoagulant, Factor XI, D-dimer, systemic thromboembolic events
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAA868Drug
3 MAA868 doses, single administration, subcutaneous,
ApixabanDrug
Apixaban 5 mg b.i.d
| Study group | Role | What they receive |
|---|---|---|
| MAA868 low dose regimen | Experimental | patients receive dose monthly. Receives: Drug: MAA868 |
| MAA868 middle dose regimen | Experimental | patients receive dose monthly. Receives: Drug: MAA868 |
| MAA868 high dose regimen | Experimental | patients receive dose monthly. Receives: Drug: MAA868 |
| Apixaban | Active comparator | Apixaban 5 mg b.i.d Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients achieving FXI inhibition ≥ 80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition
Occurrence of achieving ≥ 80% inhibition of FXI (< 20% free FXI) following 3 months of treatment.
Measured: month 3
Secondary outcomes (3)
number of patients achieving FXI inhibition ≥ 80% at trough after the first and second dose at 3 dose levels of MAA868
Occurrence of achieving ≥ 80% inhibition of FXI (< 20% free FXI) at trough on Month 1 and Month 2
Measured: Month 1 and 2
Number of patients with incidence of major or clinically relevant non-major (CRNM) bleeding events during the treatment period.
Incidence of major or clinically relevant non-major bleeding events
Measured: day 1 to day 91
the effect of MAA868 on D dimer and other thrombogenesis biomarkers as indicators of efficacy compared to compotator
Change from baseline to Day 31, Day 61 and Day 91 in thrombogenesis biomarkers (D-dimer, prothrombin fragment 1.2 (F1.2), thrombin-antithrombin III-complexes (TAT), fibrinogen).
Measured: Days 31, 61 and 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start16 Oct 2018 (estimated)
- Primary completion28 Nov 2019 (estimated)
- Study completion30 Jan 2020 (estimated)
Why it stopped: Trial cancelled before First Patient First Visit (no patient enrolled)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, open-label, blinded endpoint evaluation, active controlled, dose-range finding study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398434
- Sponsor's protocol ID
- CMAA868A2202
- Other IDs
- 2017-002741-29, 2017
- Status last verified
- Oct 2020
- First submitted
- 8 Jan 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Active-controlled, Dose-range Finding Study to Assess the Pharmacodynamic Parameters, Safety and Tolerability of MAA868 and Its Effect on Thrombogenesis Biomarkers Compared to Apixaban in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03398434
- Acronym / sponsor ID
- CMAA868A2202
- Conditions
- Atrial Fibrillation
- Keywords
- MAA868, apixaban, atrial fibrillation, anticoagulant, Factor XI, D-dimer, systemic thromboembolic events
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial cancelled before First Patient First Visit (no patient enrolled)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2018 (estimated)
- Primary completion
- 28 Nov 2019 (estimated)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This is a randomized, open-label, blinded endpoint evaluation, active controlled, dose-range finding study.
| Arm | Type | Receives |
|---|---|---|
| MAA868 low dose regimen | Experimental | Drug: MAA868patients receive dose monthly. |
| MAA868 middle dose regimen | Experimental | Drug: MAA868patients receive dose monthly. |
| MAA868 high dose regimen | Experimental | Drug: MAA868patients receive dose monthly. |
| Apixaban | Active comparator | Drug: ApixabanApixaban 5 mg b.i.d |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients ≥ 55 and < 85 years old
- Body weight between 50 and 130 kg inclusive
- Atrial fibrillation or atrial flutter, as documented by electrocardiography
- CHA2DS2-VASc risk score ≥ 2 for male and female patients. Male patients with CHA2DS2VASc risk score of 1 can be included if anticoagulation therapy is warranted.
- Either anticoagulant-naïve or receiving a stable treatment of a recommended dose of a new oral anticoagulant (NOAC) over the 8 weeks prior to screening.
Key exclusion criteria (12 listed)
- History of stroke, transient ischemic attack or systemic embolism
- History of major bleeding during treatment with an anticoagulant or antiplatelet therapy in the last 12 months
- History of traumatic or non-traumatic intracranial, intraspinal or intra-ocular bleeding
- Known bleeding diathesis or any known active bleeding site at screening or baseline
- Family history of bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAA8683 MAA868 doses, single administration, subcutaneous, | Drug | MAA868 high dose regimen, MAA868 low dose regimen, MAA868 middle dose regimen |
| ApixabanApixaban 5 mg b.i.d | Drug | Apixaban |
Primary outcome
number of patients achieving FXI inhibition ≥ 80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition
Time frame: month 3
Occurrence of achieving ≥ 80% inhibition of FXI (< 20% free FXI) following 3 months of treatment.
3 secondary outcomes
number of patients achieving FXI inhibition ≥ 80% at trough after the first and second dose at 3 dose levels of MAA868
Time frame: Month 1 and 2
Number of patients with incidence of major or clinically relevant non-major (CRNM) bleeding events during the treatment period.
Time frame: day 1 to day 91
the effect of MAA868 on D dimer and other thrombogenesis biomarkers as indicators of efficacy compared to compotator
Time frame: Days 31, 61 and 91
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MAA868 and Apixaban in people with Atrial Fibrillation, run by Novartis Pharmaceuticals.
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 12 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: withdrawn, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
number of patients achieving FXI inhibition ≥ 80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition (time frame: month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2020.