A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group

Stroke Clinical Trial

Official title:

Stroke Risk Among Users of Typical vs. Atypical Antipsychotics Stratified by Broad Age Group, a Post-authorization Safety Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04002700
• Other study ID #: CR108624
• Secondary ID: PCSESP001292
• Status: Completed
• Start date: May 6, 2019
• Est. completion date: May 31, 2019

Study information

• Verified date: August 2019
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to extend the recent Food and Drug Administration (FDA) Sentinel tabulations regarding stroke risk among new users of typical and atypical antipsychotics to participants who were aged 18-64 years and did not have dementia to participants aged 65 years and older regardless of dementia status.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1234412
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

For entry event of an initial drug exposure:

• First exposure to the particular drug(s) in the past 183 days (index date)

• Had at least 183 days of continuous observation time prior to index

• Exactly 0 condition occurrences of 'Cancer' any time in the 183 days before or on the index date

• Exactly 0 condition occurrences of 'Stroke' any time in the 183 days before or on the index date

• Exactly 0 exposures to any other typical or atypical antipsychotics any time in the 183 days before or on the index date

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Haloperidol
Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of haloperidol. No drug will be administered as part of this study.
• Typical Antipsychotics
Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of typical antipsychotics which includes Haloperidol, Loxapine, Thioridazine, Molindone, Thiothixene, Fluphenazine, Trifluoperazine, Perphenazine, Chlorpromazine. No drug will be administered as part of this study.
• Atypical Antipsychotics
Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of atypical antipsychotics which includes Aripriprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Paliperidone, Ziprasidone, Risperidone, Quetiapine, Olanzapine. No drug will be administered as part of this study.

Locations

Country	Name	City	State
United States	Janssen Investigative Site	Titusville	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Stroke as a Principal Inpatient Diagnosis	Number of participants with stroke in each target cohort versus comparator cohort (aged 65 years and older) per person years at risk will be reported. It is defined defined by the presence of the relevant ICD codes (ICD-9 or ICD-10 according to date) in the inpatient setting as the primary diagnoses.	Up to 16 years (from 01-January-2002 through 31-December-2017)
Secondary	Number of Participants at Stroke Risk when Compared Among New Users of Typical Antipsychotics/Haloperidol versus Atypical Antipsychotics	The number of participants with the risk of stroke among participants exposed to typical antipsychotics versus atypical antipsychotics will be reported.	Up to 16 years (from 01-January-2002 through 31-December-2017)