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Acute Coronary SyndromePhase 4APPROACHNCT02789917

APixaban vs. PhenpRocoumon in Patients With ACS and AF: APPROACH-ACS-AF

A Phase 4 study testing Dual Therapy and Triple Therapy in people with Acute Coronary Syndrome and Atrial Fibrillation, run by LMU Klinikum at 16 sites in Germany.

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

It is hypothesised that a dual therapy strategy by oral anticoagulation with the new Factor-Xa-inhibitor apixaban plus clopidogrel is superior to a triple therapy regimen with phenprocoumon plus acetylsalicylic acid (ASA) and clopidogrel with respect to avoiding bleeding events in patients with atrial fibrillation… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dual Therapy and Triple Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
403 participants
Where
16 sitesGermany
Study dates
Jun 2016to Aug 2020
Phase
Phase 4
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

  • Signed written informed consent
  • Patients with an ACS after successful percutaneous coronary intervention
  • Indication for oral anticoagulation due to non-valvular atrial fibrillation or atrial flutter (CHA2DS2VASc score ≥ 2)
  • Males and Females, ages ≥ 18
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
  • Women must not be breastfeeding
  • WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs plus 30 days (duration of ovulatory cycle) post-treatment completion. However they must still undergo pregnancy testing.

Who cannot join

  • Age < 18 years
  • History of intracranial bleeding
  • Active bleeding
  • History of TIMI major bleeding according to TIMI and/or type ≥3b BARC criteria in the last 6 months
  • History of peptic ulcer in the last 6 months
  • Subjects with a history of a complicated or prolonged cardiogenic shock in the last two weeks prior to randomization. A complicated or prolonged cardiogenic shock is defined by a cardiogenic shock that required mechanical ventilation or the cardiovascular support with positive inotropic drugs (i.v. catecholamine) for ≥7 days
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  • Planned major surgery during the study course with planned discontinuation of antithrombotic therapy
  • Expected life expectancy of less than a year and/or severe illness (e.g. malignancy)
  • Mechanical valve replacement
  • Valvular atrial fibrillation
  • Severe renal insufficiency (creatinine clearance < 30ml/min)
  • Severe liver insufficiency (Child-Pugh-class C) or elevated hepatic transaminases >2 times the upper limit of normal
  • Patient's inability to fully comply with the study protocol
  • Known or persistent abuse of medication, drugs or alcohol reliable by the investigator in individual cases
  • Subjects with known contraindications to apixaban, phenprocoumon, clopidogrel or ASA treatment, which are hypersensitive to the drug substance or any component of the product
  • Relevant hematologic deviations: platelet count < 50 G/L or platelet count > 600 G/L
  • Current or planned pregnancy or nursing women, women 90 days after childbirth. Females of childbearing potential, who do not use and are not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Germany16 sites

  • Universitätsklinikum der RWTH Aachen

    Aachen

  • Charité, Campus Benjamin Franklin

    Berlin

  • Charité, Campus Virchow-Klinikum

    Berlin

  • Klinikum Coburg

    Coburg

  • Westdeutsches Herzzentrum am Universitätsklinikum

    Essen

  • Universitätsmedizin Göttingen

    Göttingen

  • Universitätsmedizin Greifswald

    Greifswald

  • Universitätsklinikum Heidelberg

    Heidelberg

  • UKHS Campus Kiel

    Kiel

  • Klinikum Lüdenscheid

    Lüdenscheid

  • Universitätsmedizin Mainz

    Mainz

  • Universitätsklinikum Mannheim

    Mannheim

  • Klinikum Augustinum

    München

  • Städtisches Klinikum München-Neuperlach

    München

  • Munich University Hospital

    Munich, Bavaria, 81377

  • Universitätsmedizin Rostock

    Rostock

Other trials in Germany

About this study

Official title: APixaban Versus PhenpRocoumon: Oral AntiCoagulation Plus Antiplatelet tHerapy in Patients With Acute Coronary Syndrome and Atrial Fibrillation

It is hypothesised that a dual therapy strategy by oral anticoagulation with the new Factor-Xa-inhibitor apixaban plus clopidogrel is superior to a triple therapy regimen with phenprocoumon plus acetylsalicylic acid (ASA) and clopidogrel with respect to avoiding bleeding events in patients with atrial fibrillation undergoing percutaneous coronary intervention in the setting of an acute coronary syndrome.

Read the detailed description

Patients with atrial fibrillation (AF) presenting an acute coronary syndrome (ACS) and undergoing PCI require a triple therapy with a combination of oral anticoagulation (OAC) and dual anti-platelet therapy. Current guidelines recommend a regimen consisting of aspirin, clopidogrel and an oral anticoagulant. Although effective in preventing recurrent ischemia, triple therapy confers an elevated bleeding risk, which also has a major impact on the patients' prognosis and survival. Data from one randomized trial suggest that omitting aspirin in patients with indication for triple therapy may reduce the risk of bleeding without an increase of the rate of ischemic events. In addition, the recently introduced non-vitamin-K oral anticoagulants (NOACs) show less bleeding events as compared to vitamin-K antagonist in AF patients. In this trial it is postulated that a dual therapy consisting of the factor-Xa inhibitor apixaban and clopidogrel is associated with significant lower bleeding rates as compared to traditional triple therapy with aspirin, clopidogrel and a vitamin K antagonist (VKA). To test this hypothesis, patients with atrial fibrillation, who underwent PCI in the setting of an ACS will be randomized to either a dual therapy (apixaban+clopidogrel) or a triple therapy (aspirin+clopiodgrel+VKA). The patients will be followed-up for 6 months after randomization.

Being tested
Dual Therapy, Triple Therapy
Keywords
ACS, Triple-Therapy, AF, oral anticoagulation (OAC), non-vitamin-K oral anticoagulant (NOAC)
Medical subject headings
Acute Coronary Syndrome, Atrial Fibrillation, Coronary Artery Disease

What participants receive

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

  • Dual TherapyOther

    Combination of Apixaban 5mg/dl (or in reduced dosing of 2.5 mg/d depending on age, renal function and body weight) in combination with Clopidogrel 75 mg/d for 6 months.

  • Triple TherapyOther

    HAS-BLED-Score <3:

    Combination of Phrenprocoumon (INR 2.0-2.5), Clopidogrel (75mg/d) and ASA (100 mg/d) for 6 months.

    HAS-BLED-Score ≥ 3:

    Combination of Phrenprocoumon (INR 2.0-2.5), Clopidogrel (75mg/d) and ASA (100 mg/d) for 1 month followed by Phrenprocoumon (INR 2.0-3.0) and Clopidogrel (75mg/d) for 5 months.

Study groups in NCT02789917
Study groupRoleWhat they receive
Dual therapy (incl. NOAC)ExperimentalApixaban plus Clopidogrel
Receives: Other: Dual Therapy
Triple therapy (incl. VKA)Active comparatorPhrenprocoumon plus Clopidogrel plus ASA
Receives: Other: Triple Therapy

What is being measured

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

  1. The combined endpoint of moderate or major bleeding complications during the initial hospitalization and follow up (Bleeding Academic Research Consortium (BARC) type ≥ 2 bleeding)

    Measured: up to 6 months after randomization

Secondary outcomes (2)

  1. Combined event of death, myocardial infarction, definite stent thrombosis, stroke/other systemic thromboembolism and all the individual components of the composite secondary endpoint

    Measured: up to 6 months after randomization

  2. Bleeding complications (Major bleeding: BARC > 3b bleeding)

    Measured: up to 6 months after randomization

Timeline

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

  1. First posted3 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionAug 2020
  4. Study completionAug 2020

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
403 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02789917
Sponsor's protocol ID
GE IDE MucT003-16
Acronym
APPROACH
Status last verified
Aug 2020
First submitted
24 May 2016
Last updated
14 Aug 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Inclusion in central DZHK Database (German Centre for Cardiovascular Research)

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dual Therapy and Triple Therapy in people with Acute Coronary Syndrome and Atrial Fibrillation, run by LMU Klinikum at 16 sites in Germany.

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 7 inclusion and 17 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 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Germany. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

The combined endpoint of moderate or major bleeding complications during the initial hospitalization and follow up (Bleeding Academic Research Consortium (BARC) type ≥ 2 bleeding) (time frame: up to 6 months after randomization). 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 NCT02789917.

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 14 Aug 2020.

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