Dapagliflozin Effect in Cognitive Impairment in Stroke Trial (DECIST)

October 3, 2022 updated by: Jaime Daniel Mondragon

Background: Dementia is an international public health problem, affecting approximately 50,000,000 people worldwide in 2018 and will triple by 2050; furthermore, reaching an approximate cost of 4 billion dollars. Given its high worldwide prevalence and probable underdiagnosis, the international guidelines for the assessment of dementia syndromes recommend the assessment of cognitive impairment in patients over 55 years of age as part of clinical practice in patients who presented an ischemic cerebrovascular event. Several risk factors associated with cognitive impairment in cerebrovascular disease are identified in the literature: 1) demographic factors (e.g., age over 65 years and female sex); 2) risk factors present prior to the ischemic stroke (e.g., cognitive impairment, physical impairment); 3) factors utilized to assess the severity of an ischemic stroke (e.g., supratentorial location, ischemic stroke in the dominant hemisphere, recurrence of ischemic strokes); 4) post-ischemic stroke factors (e.g., delirium and seizures); and 5) factors associated with neuroimaging findings (e.g., cerebral small vessel disease, cortical atrophy, and medial temporal lobe atrophy).

This is a randomized controlled trial in individuals with an acute ischemic stroke without dementia that will be treated with 10mg dapagliflozin PO q24h for 12 months and standard treatment against only standard treatment (i.e., statins, platelet antiaggregant, and hypoglycemic medications) when appropriate. The outcome measure evaluated will be global cognitive function. Cardiovascular risk factors will be associated with cognitive decline.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Detailed Description: This is a double-blind, randomized, placebo-controlled, parallel-group, 12-month longitudinal study performed at a single center (Hospital General de Zona con Medicina Familiar IMSS No. 21, León Guanajuato, México) designed to investigate the effect of dapagliflozin in participants with a recent acute stroke but no history of dementia (CDR score ≤ 0.5). A total of 270 participants are to be included (i.e., 135 on each arm).

Overall objective: To assess the effect of Dapagliflozin on cardiovascular risk (i.e., the volume of epicardial fat, volume of total carotid atherosclerotic plaque, and coronary artery calcium score) in patients with ischemic cerebrovascular disease dependent on global cognitive function at a second level teaching hospital in Mexico.

Statistical analysis: Descriptive statistics will be reported for all included variables. Statistical analysis will be performed using SPSS 25 (SPSS Inc., Chicago, IL). All variables will be examined to determine the existence of outliers and whether they meet the assumptions about a Gaussian distribution. The Shapiro-Wilk tests will be used to determine normality distribution, as well as visual inspection of histograms and Q-Q plots. Demographic and clinical variables will be summarized in proportions and percentages. The categorical variables will be evaluated to determine statistical inferences with the Mann-Whitney U test. Continuous variables will be assessed for statistical inferences using t-tests (e.g., simple, paired, one, and two samples) and Levene's test to assess equality of variances. The Kaplan-Meier method will be used to calculate the distributions of mortality and development of mild amnestic cognitive disorder and dementia syndrome. The Gehan-Breslow-Wilcoxon method will be used to assess the equality of the mortality distributions and the development of mild amnestic cognitive disorder or dementia syndrome. A multivariate analysis will be performed with a Cox regression model to assess the variables that predict mortality, and the development of a mild amnestic cognitive disorder, or dementia syndrome at 6 and 12 months in case there are differences in mortality distributions. Statistical significance will be set at p=0.05 and a Bonferroni correction will be performed for multiple comparisons.

Study Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Guanajuato
      • León, Guanajuato, Mexico, 37380
        • Recruiting
        • Hospital General de Zona IMSS 21
        • Contact:
        • Contact:
          • Gabriela G López-Hernández, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages of 60 and 80 years
  • Both sexes
  • Cerebrovascular ischemic event within 15 days
  • Clinical dementia rating score ≤ 0.5
  • Signed informed consent

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Aphasia
  • Incomplete neuropsychological battery
  • Previously diagnosed dementia
  • Cerebrovascular ischemic stroke older than 15 days
  • History of hemorrhagic cerebrovascular event
  • Neoplasia diagnosis or evidence of a metastatic process, glomerular filtration rate < 45 mL/min at the time of inclusion
  • Liver enzyme test alterations (i.e., aspartate transaminase or alanine transaminase three times greater than normal levels, total bilirubin> 2.0 mg/dL
  • Previously taking SGLT2 inhibitors
  • History of diabetic ketoacidosis
  • Recurrent urinary tract infections
  • Psychiatric disorders (e.g., dementia, psychosis, bipolar disorder, among others).
  • Less than a 12-month follow-up
  • Inability to perform chest CT (e.g., claustrophobia)
  • Incomplete medical files pertaining to the variables of interest
  • Less than 12-month follow-up
  • Decision to withdraw their participation at any moment
  • Poor adherence to medical treatment
  • Reported and documented disease complications or adverse effects (e.g., severe glycemic imbalance, diabetic ketoacidosis, or hyperosmolar hyperglycemic state, altered hepatic enzyme tests)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapagliflozin
10mg PO q24h for 12 months plus standard treatment with statins, platelet antiaggregant, and hypoglycemic medications.
Drug: Dapagliflozin 10mg Tab
10mg PO q24h for 12 months
Other Names:
  • FORXIGA
Drug: Statins (Cardiovascular Agents)
Atorvastatin 20mg PO q24h or Pravastatin 20mg PO q24h or Rosuvastatin 10mg PO q24h
Other Names:
  • Rosuvastatin
  • Atorvastatin
  • Pravastatin
Drug: Platelet Antiaggregant
Clopidogrel 75mg PO q24h or Acetylsalicylic acid 100mg PO q24h
Other Names:
  • Clopidogrel
  • Acetylsalicylic acid
Drug: Antidiabetic
Previously established medical treatment for type 2 diabetes will be maintained.
Other Names:
  • Cycloset
  • Thiazolidinediones
  • Insulin lispro
  • Sulfonylureas
  • Meglitinides
  • Biguanides
  • α-Glucosidase inhibitors
  • Inhibitors of dipeptidyl peptidase 4
  • Insulin glargine
  • Isophane insulin
Active Comparator: Standard treatment
Standard treatment with statins, platelet antiaggregant, and hypoglycemic medications.
Drug: Statins (Cardiovascular Agents)
Atorvastatin 20mg PO q24h or Pravastatin 20mg PO q24h or Rosuvastatin 10mg PO q24h
Other Names:
  • Rosuvastatin
  • Atorvastatin
  • Pravastatin
Drug: Platelet Antiaggregant
Clopidogrel 75mg PO q24h or Acetylsalicylic acid 100mg PO q24h
Other Names:
  • Clopidogrel
  • Acetylsalicylic acid
Drug: Antidiabetic
Previously established medical treatment for type 2 diabetes will be maintained.
Other Names:
  • Cycloset
  • Thiazolidinediones
  • Insulin lispro
  • Sulfonylureas
  • Meglitinides
  • Biguanides
  • α-Glucosidase inhibitors
  • Inhibitors of dipeptidyl peptidase 4
  • Insulin glargine
  • Isophane insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Dementia Rating score as a proxy of cognitive deterioration
Time Frame: 6 and 12 months
Time-to-event analysis using the Kaplan-meier survival analysis via increase in Clinical Dementia Rating score greter or equal to 0.5
6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of strokes after initial cerebrovascular event
Time Frame: 12 months
Independent stroke events
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects due to Dapagliflozin
Time Frame: 12 months
Adverse effects reported due to the use of dapagliflozin
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaime Daniel Mondragon

Collaborators

University Medical Center Groningen
Hospital General León
Hospital General de Zona IMSS N0. 21

Investigators

  • Study Chair: Gabriela G López-Hernández, M.D., Hospital General de Zona IMSS 21
  • Study Chair: Lizeth C Ramírez-Zamudio, M.D., Hospital General de Zona IMSS 21
  • Principal Investigator: Jaime D Mondragón, M.D., Ph.D., University Medical Center Groningen, Department of Neurology, Alzheimer Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

September 20, 2022

First Submitted That Met QC Criteria

October 3, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-2022-1005-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The study protocol, statistical analysis plan and informed consent form are available through the IMSS platform or upon request.

IPD Sharing Time Frame

Starting august 2022

IPD Sharing Access Criteria

Request IMSS institutional board

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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