Studies on the impact of vasoconstrictors on the risk of myocardial infarction and stroke (PGRx-VASO)

Study identification

• EU PAS number:
  EUPAS10239
• Study ID:
  22729
• Official title and acronym:
  Studies on the impact of vasoconstrictors on the risk of myocardial infarction and stroke (PGRx-VASO)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The main assessment criterion that served for the study power estimation is to determine whether exposure to vasoconstrictors is associated with an increased risk of occurrence of stroke and / or of myocardial infarction (MI). The endpoint is composite:- Haemorrhagic or ischemic Stroke - Myocardial infarction (MI) Other objectives are to determine if exposure to vasoconstrictors is associated with an increased risk of occurrence of MI and to determine whether exposure to vasoconstrictors is associated with an increased risk of occurrence of haemorrhagic or ischemic stroke.The study design is a case-crossover study of patients with MI or stroke. The case-crossover analysis will compare drug exposure between a risk-time-period and a reference-time-period within the same patient.Population is recruited all over France (PGRx system) that has shown good representativity of patients with myocardial infarction or stroke.Medical information is entered by cardiologists and neurovascular specialists in the PGRx system. Drug exposure is obtained from cardiologists and neurovascular specialists, and patients through standardized and validated telephone interviews.A total of 2700 patients with MI or stroke (1350 each) will be needed to achieve a power of 80% to detect an Odds ratio between 1.51 and 1.76 depending on the VC utilisation on the reference period (1 or 2 % respectively), for the comparison of VCs to no VC use.
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World Studies, LA-SER Research

France

United Kingdom

Networks

PGRx®

France

United Kingdom

Study timelines

Date when funding contract was signed

Planned:20/12/2013

Actual:20/12/2013

Study start date

Planned:01/10/2013

Actual:01/10/2013

Data analysis start date

Planned:01/12/2015

Actual:06/07/2016

Date of final study report

Planned:01/02/2016

Actual:28/10/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Severals

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable