Concomitant Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Small Vessel Stroke
Recruiting
Phase 3Interventional Study
Ischemic Stroke
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
600 (estimated)
Sponsor
Kafrelsheikh University · Other
Who this trial is looking for
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Along with the current clinical trial, the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever small vessel stroke patients treated with clopidogrel and aspirin assessed through NIHSS, mRS, and possible adverse effects.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* males and females aged 18-75
* first-ever moderate and small vessel Stroke
* Patients are not eligible for rt-PA treatment
Exclusion Criteria:
* The investigators excluded patients who had rapidly resolving symptoms before imaging results, and patients with a known history o…
Inclusion Criteria:
* males and females aged 18-75
* first-ever moderate and small vessel Stroke
* Patients are not eligible for rt-PA treatment
Exclusion Criteria:
* The investigators excluded patients who had rapidly resolving symptoms before imaging results, and patients with a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis, history of head trauma with a residual neurological deficit).
* the investigators excluded patients who had clinical seizures at the onset of their stroke, as well as those who had symptoms of any major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks, and those who were on warfarin, regular ticagrelor during the week before admission, or chemotherapy within the previous year.
* The investigators excluded patients with active peptic ulcers, GIT surgery, bleeding history within the last year, and those with a history of major surgery within the last three months.
* The investigators ruled out of our trial patients who had a known allergy to the study drugs and those with INR \> 1.4 or P.T. \>18 or blood glucose level \< 50 or \> 400 mg/DL or blood pressure \< 90/60 or \> 185/110 mmHg on admission or Platelets \< 100,000.
* The investigators excluded pregnant and lactating patients and those with stroke due to venous thrombosis and stroke following cardiac arrest or profuse hypotension ineligible for our trial.
* The investigators excluded patients who were regular users of drugs that affect clopidogrel metabolism, such as ketoconazole, dihydropyridine calcium channel blockers, and rifampin.
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