Status: Ongoing First registered on: 01/04/2019
Last updated on: 06/03/2020
1. Study identification
EU PAS Register NumberEUPAS29177
Official titleDual antiplatelet therapy for prolonged secondary prevention of acute coronary events
Study title acronymDEEPSPACE
Study typeOther: Historical cohort study using the SNDS, the French nationwide claims database
Brief description of the studyDual 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).
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Professor
Last name Moore
First name Nicholas
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed21/06/2019
Start date of data collection31/12/201926/02/2020
Start date of data analysis01/01/2020
Date of interim report, if expected
Date of final study report31/12/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyFrench Ministry of Health (PHRCN-18-0745)100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Moore
First name Nicholas
Address line 1University of Bordeaux
Address line 2146 Rue Léo Saignat 
Address line 3Bâtiment du Tondu - Case 41 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
Public Enquiries
Title Professor 
Last name Moore 
First name Nicholas 
Address line 1University of Bordeaux 
Address line 2146 Rue Léo Saignat 
Address line 3Bâtiment du Tondu - Case 41 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
Top