StrokeNCT04002700
A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group
An observational study of Stroke, run by Janssen Research & Development, LLC at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Haloperidol, Typical Antipsychotics and Atypical Antipsychotics
- How many people
- 1,234,412 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2019to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is the participants in (any of) the target or comparator cohorts. Each target and comparator cohort will be drawn from the appropriate database: IBM MarketScan Commercial Database (CCAE) if the participants are aged 18-64 years and IBM MarketScan Medicare Supplemental Database (MDCR) if participants are aged greater than or equal to (>=) 65 years.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Janssen Investigative Site
Titusville, New Jersey, 08560
About this study
Official title: Stroke Risk Among Users of Typical vs. Atypical Antipsychotics Stratified by Broad Age Group, a Post-authorization Safety Study
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.
- Conditions
- Stroke
- Being tested
- Haloperidol, Typical Antipsychotics, Atypical Antipsychotics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaloperidolDrug
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 AntipsychoticsDrug
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 AntipsychoticsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Target Cohort 1 | Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years without a recent dementia diagnosis. Receives: Drug: Typical Antipsychotics | |
| Target Cohort 2 | Participants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years without a recent dementia diagnosis. Receives: Drug: Haloperidol | |
| Target Cohort 3 | Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged greater than or equal to (>=) 65 years. Receives: Drug: Typical Antipsychotics | |
| Target Cohort 4 | Participants will be analyzed for stroke-risk who are new users of haloperidol aged >= 65 year. Receives: Drug: Haloperidol | |
| Target Cohort 5 | Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years. Receives: Drug: Typical Antipsychotics | |
| Target Cohort 6 | Participants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years. Receives: Drug: Haloperidol | |
| Comparator Cohort 7 | Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years without a recent dementia diagnosis. Receives: Drug: Atypical Antipsychotics | |
| Comparator Cohort 8 | Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged >= 65 years. Receives: Drug: Atypical Antipsychotics | |
| Comparator Cohort 9 | Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years. Receives: Drug: Atypical Antipsychotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 16 years (from 01-January-2002 through 31-December-2017)
Secondary outcomes (1)
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.
Measured: Up to 16 years (from 01-January-2002 through 31-December-2017)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start6 May 2019
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,234,412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002700
- Sponsor's protocol ID
- CR108624
- Other IDs
- PCSESP001292
- Status last verified
- Jun 2025
- First submitted
- 28 Jun 2019
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Risk Among Users of Typical vs. Atypical Antipsychotics Stratified by Broad Age Group, a Post-authorization Safety Study
- ClinicalTrials.gov ID
- NCT04002700
- Acronym / sponsor ID
- CR108624
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,234,412 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 6 May 2019 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Target Cohort 1 | – | Drug: Typical AntipsychoticsParticipants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years without a recent dementia diagnosis. |
| Target Cohort 2 | – | Drug: HaloperidolParticipants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years without a recent dementia diagnosis. |
| Target Cohort 3 | – | Drug: Typical AntipsychoticsParticipants will be analyzed for stroke-risk who are new users of typical antipsychotics aged greater than or equal to (>=) 65 years. |
| Target Cohort 4 | – | Drug: HaloperidolParticipants will be analyzed for stroke-risk who are new users of haloperidol aged >= 65 year. |
| Target Cohort 5 | – | Drug: Typical AntipsychoticsParticipants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years. |
| Target Cohort 6 | – | Drug: HaloperidolParticipants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years. |
| Comparator Cohort 7 | – | Drug: Atypical AntipsychoticsParticipants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years without a recent dementia diagnosis. |
| Comparator Cohort 8 | – | Drug: Atypical AntipsychoticsParticipants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged >= 65 years. |
| Comparator Cohort 9 | – | Drug: Atypical AntipsychoticsParticipants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is the participants in (any of) the target or comparator cohorts. Each target and comparator cohort will be drawn from the appropriate database: IBM MarketScan Commercial Database (CCAE) if the participants are aged 18-64 years and IBM MarketScan Medicare Supplemental Database (MDCR) if participants are aged greater than or equal to (>=) 65 years.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HaloperidolStroke 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. | Drug | Target Cohort 2, Target Cohort 4, Target Cohort 6 |
| Typical AntipsychoticsStroke 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. | Drug | Target Cohort 1, Target Cohort 3, Target Cohort 5 |
| Atypical AntipsychoticsStroke 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. | Drug | Comparator Cohort 7, Comparator Cohort 8, Comparator Cohort 9 |
Primary outcome
Number of Participants with Stroke as a Principal Inpatient Diagnosis
Time frame: Up to 16 years (from 01-January-2002 through 31-December-2017)
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.
1 secondary outcome
Number of Participants at Stroke Risk when Compared Among New Users of Typical Antipsychotics/Haloperidol versus Atypical Antipsychotics
Time frame: Up to 16 years (from 01-January-2002 through 31-December-2017)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Stroke as a Principal Inpatient Diagnosis (time frame: Up to 16 years (from 01-January-2002 through 31-December-2017)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.