Dual antiplatelet therapy for prolonged secondary prevention of acute coronary events (DEEPSPACE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44220
• EU PAS number:
  EUPAS29177
• Study ID:
  44220
• Official title and acronym:
  Dual antiplatelet therapy for prolonged secondary prevention of acute coronary events (DEEPSPACE)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Dual antiplatelet therapy (DAPT) is recommended for one year after an acute coronary syndrome (ACS), but the benefits and risks of longer duration of DAPT remain disputed. The PEGASUS-TIMI 54 clinical trial found a beneficial effect of prolonged DAPT with ticagrelor in chronic stable high-risk patients, but its generalizability is uncertain. The latest recommendations from the European Society of Cardiology remain relatively conservative considering that extension of DAPT beyond 1 year (up to 3 years) in the form of aspirin plus ticagrelor 60 mg bid may be considered in patients who have tolerated DAPT without a bleeding complication and having an additional risk factor for ischaemic events. In this context, the DEEPSPACE study purpose is to compare in real-life event rate (i.e. composite criterion of ACS, stroke, major bleeding, or death for main outcome, and individual events for secondary outcomes) on DAPT with any of the three P2Y12 antagonists (clopidogrel, ticagrelor, or prasugrel) plus aspirin to aspirin alone, over 3 years beyond one year after ACS, using the French nationwide claims database (SNDS). The cohort will include all patients hospitalised for an initial ACS (trigger event) between 2013 and 2014, and having one year of event-free DAPT after this initial ACS. The index date will be the one-year anniversary date for the ACS discharge, and each patient will be followed 3 years or until death and will have 2-year history prior the index date in the database. It is expected 50 000 patients included in the study after one-year event-free on DAPT with an event occurrence estimate to 5 200 composite events and 1 000 deaths. The outcomes will be described during the exposure period according to treatment groups in terms of crude incidence rate (Normal approximation), cumulative incidence rate (Kaplan-Meier estimator or Cumulative Incidence Function), and risk factors of outcomes (Cox proportional hazards models or Fine and Grey models).
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual: 21/06/2019

Study start date

Planned: 31/12/2019

Actual: 26/02/2020

Data analysis start date

Planned: 03/05/2021

Date of final study report

Planned: 31/03/2023

Sources of funding

Other

More details on funding

French Ministry of Health (PHRCN-18-0745)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable