Prospective Record Of the use of Dabigatran in patients with Acute Stroke or TIA (PRODAST)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective, multi-center observational study

Study drug and medical condition

• Name of medicine:
  PRADAXA
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AA) Vitamin K antagonists

  Vitamin K antagonists

  (B01AB) Heparin group

  Heparin group

  (B01AC) Platelet aggregation inhibitors excl. heparin

  Platelet aggregation inhibitors excl. heparin

  (B01AE) Direct thrombin inhibitors

  Direct thrombin inhibitors

  (B01AF) Direct factor Xa inhibitors

  Direct factor Xa inhibitors
• Medical condition to be studied:
  Ischaemic stroke

  Transient ischaemic attack

  Atrial fibrillation

Population studied

• Short description of the study population:
  The study population included patients aged 18 years or older diagnosed with recent (≤ 1 week from index) ischemic stroke or transient ischaemic attack (TIA) and with confirmed non-valvular atrial fibrillation (AF) receiving treatment with dabigatran, vitamin K antagonists (VKAs), antiplatelets only or no oral antithrombotic treatment identified from July 2015 to November 2020.; Inclusion criteria:; 1. Age ≥18 years at enrollment; 2. Male or female patient willing and able to provide written informed consent for data transmission. For patients who are not legally competent to sign this informed consent for data transmission exceptions/special cases.; 3. Patient with ischemic stroke or TIA within the last 7 days.; 4. Patient diagnosed with non-valvular AF. Documentation of AF by 12 lead ECG, ECG rhythm strip, monitor print-out, pacemaker/ICD electrocardiogram, Holter ECG (duration of AF episode at least 30 seconds) or written physician´s diagnosis prior to index event needed for all enrolled patients.; 5. Patients treated with either dabigatran, VKA, antiplatelets only or no oral antithrombotic treatment at all.; ; Exclusion criteria:; 1. Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention (surgical or non-surgical) during the next 3 months.; 2. Current participation in any randomized clinical trial of an experimental drug or device.; 3. Women of childbearing age without anamnestic exclusion of pregnancy or not using an effective contraception or nursing mothers.; 4. In case, it will be determined at baseline or at discharge that patients have been treated in deviation from the effective summary of product characteristics (SmPC) for dabigatran (Pradaxa), sect. 4.1 (field of application) and/or 4.3 (contraindication), those patients will not be included in the follow-up part of the study.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with stroke and atrial fibrillation
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  - if 3-month major bleeding event rate following TIA or ischemic stroke in patients with AF is not significantly increased with dabigatran administered early compared to dabigatran treatment started after 7 days or VKA started at any time - occurrences of major bleeding over time and optimal time point for dabigatran administration - recurrent stroke rates under treatment (dabigatran, VKA etc.)
• Outcomes:
  major bleeding event rate within 3 months following the index event, - stroke (hemorrhagic, ischemic or of uncertain classification) - transient ischemic attack (TIA) - systemic/pulmonary embolism - myocardial infarction - life-threatening/gastrointestinal bleeding events - any cause of death (non-vascular, vascular or unknown cause) - point of time/reason of withdrawal/change of medication - compliance/treatment persistance - complications, AE/SAE
• Data analysis plan:
  Analysis of the primary endpoint will be based on the number of major bleeding events within 3 months of follow-up with respect to person-time under medication. For the analysis time-to-event methodology, namely Cox proportional-hazards models, will be used. As change of therapy is allowed during the observation period, each patient can contribute person-time to more than one treatment. As this is the case and risk for major bleeding is assumed to be higher at the beginning of the observation period than at the end, treatment will be included in the regression model as time-dependent variable, i.e. using counting process syntax. To account for possible confounders of major bleeding, either conventional multiple regression or propensity scores (either as a PS-matched or PS-adjusted analysis) will be used.

Documents

Study results

Prodast_report 15MAR23_final_geschwärzt