PROspective Study to OPTimize thE HEALTH of Patients With TIAs (Transient Ischemic Attacks) and Stroke Admitted to the Hamad General Hospital

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02868723
• Date of registration: 30/06/2016
• Prospective Registration: Yes
• Primary sponsor: Hamad Medical Corporation
• Public title: PROspective Study to OPTimize thE HEALTH of Patients With TIAs (Transient Ischemic Attacks) and Stroke Admitted to the Hamad General Hospital PROMOTE-HEALTH
• Scientific title: PROspective Study to OPTimize thE HEALTH of Patients With TIAS (Transient Ischemic Attack) and Stroke Admitted to the Hamad General Hospital
• Date of first enrolment: November 12, 2017
• Target sample size: 400
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02868723
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Qatar

Contacts

• Name: YAHIA Z BASHIER IMAM, MBBS,MRCP,MRCPE
• Affiliation: Hamad Medical Corporation

• Name: YAHIA Z BASHIER IMAM, MD,MRCP,MRCPE

• Name: YAHIA Z BASHIER IMAM, MBBS,MD,MRCP,MRCPE

Key inclusion & exclusion criteria

Inclusion Criteria:

- ISCHEMIC STROKE OR TIA including ocular stroke such as Amaurosis Fugax, within the
past year (not intracranial hemorrhage or due to trauma, malignancy or cardio-embolic
related to structural heart disease)

- MEETS AT LEAST ONE OF THE FOLLOWING THREE CRITERIA:

- systolic Bp>140 mmHg but <200 mmHg (at 24 HR from admission/if clinic visit 3
readings 5 minutes apart)

- fasting LDL cholestrol >2.0 (MEASURED WITHIN PREVIOUS 6 MONTH)

- total: HDL cholestrol ratio >4.0 (measured within previous 6 month)

- Willing to participate (by signing consent form)and willing to return for
study-related scheduled follow up visits for one year from the time of enrollment into
the study

Exclusion Criteria:

- Participation in concurrent interventional trial related to stroke or vascular disease

- Any condition, including foreshortened life-expectancy or severe comorbidities that
would preclude treatment benefit or 12-month follow up.

- Institutionalized in a long term care facility

- Already on maximal therapy for risk factors:

- On 3 ANTI HTN drugs at maximal dose (if htn is inclusion criteria)

- On maximal dose of statin (if elevated LDL-cholesterol is inclusion criteria)

- CT or MRI shows evidence of primary intracranial hemorrhage or neoplasm

- Active coronary artery disease

- Severe Renal on hemo-dialysis(HD) or Severe Hepatic dysfunction

- Cognitive dysfunction severe enough to interfere with patients ability to give
informed consent

- Severe systemic illness that will not allow for the patient to complete the one year
trial

- History of intolerance to statins or commonly used anti-hypertensive
medications(intolerance/contraindication to statin(if elevated LDL-c is the inclusion
criteria)

- Unable to tolerate antiplatelet agents

- Decline of consent

- Reside outside Qatar

- Unable to participate (due cognition, mobility, language barrier)



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Transient Ischemic Attack (TIA)

Stroke

Intervention(s)

Other: Aggressive Management

Primary Outcome(s)

Progression/regression of 3D plaque volume [Time Frame: one year]

Secondary Outcome(s)

Measurement of Lipid levels [Time Frame: one year]

Measurement of blood pressure [Time Frame: one year]

Secondary ID(s)

MRC-IRGC-02-NI-059

Source(s) of Monetary Support

Please refer to primary and secondary sponsors