Clinical trial: Aspirin Or Warfarin To Prevent Stroke (NCT00004728)

Eligibility criteria:
Inclusion Criteria:

          -  TIA or non-severe stroke within 90 days prior to randomization (including day 90)

          -  Modified Rankin score of < 3

          -  High grade stenosis (50 to 99 percent) of a major intracranial artery (carotid artery,
             MCA stem (M1), vertebral artery,and basilar artery) documented by conventional
             angiography within 90 days prior to randomization (including day 90)

          -  TIA or stroke is attributed to high grade intracranial stenosis

          -  Age > 40 years

          -  Patient is able to follow an outpatient protocol(requiring monthly blood tests and
             clinic visits every four months for the duration of the study) and is available by
             telephone

          -  Patient understands the purpose and requirements of the study, can make him/herself
             understood, and has provided informed consent

        Exclusion Criteria:

          -  Extracranial carotid stenosis (> 50 percent) ipsilateral to stenosis of the
             intracranial carotid artery or MCA (ie.tandem stenoses, either of which could have
             caused patient's symptoms)

          -  Isolated stenosis of the anterior cerebral artery, posterior cerebral artery, MCA
             division, or a distal branch of the MCA

          -  Intracranial or extracranial arterial dissection, Moya Moya disease, vasculitis,
             radiation induced vasculopathy, fibromuscular dysplasia

          -  Presence of any of the following unequivocal cardiac sources of embolism: chronic or
             paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis,
             intracardiac clot or vegetation, myocardial infarction within three months, dilated
             cardiomyopathy, left atrial spontaneous echo contrast

          -  A contraindication to the use of either warfarin or aspirin e.g. active peptic ulcer
             disease, active bleeding diathesis, platelets < 100,000*, hematocrit < 30*, clotting
             factor abnormality that increases the risk of bleeding, alcohol or substance abuse,
             severe gait instability, cerebral hemorrhage, systemic hemorrhage within the past
             year, severe liver impairment (SGOT > 3x normal*, cirrhosis), allergy to aspirin or
             warfarin, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic
             pressure > 115mm Hg), positive stool guaiac that is not attributable to hemorrhoids,
             creatinine > 3.0*

          -  Indication for intravenous heparin beyond randomization

          -  A severe neurological deficit that renders the patient incapable of living
             independently

          -  Dementia or psychiatric problem that prevents the patient from following an outpatient
             program reliably

          -  Co-morbid conditions that may limit survival to less than five years

          -  Pregnancy or female in age range of childbearing potential who is not using
             contraception

          -  Enrollment in another study that would conflict with the current study

          -  Excluded because difficult to measure percent stenosis of these small arteries,
             lesions are uncommon, and prognosis of patients - With these lesions is unknown * on
             most recent test done within 90 days prior to randomization, including day 90
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.


Patient description (medical language): A 23-year-old man comes to the emergency department following an episode of syncope.  He was working out when he felt dizzy and passed out without head injury.  He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions.  The patient does not use tobacco, alcohol, or illicit drugs.  His father died suddenly at age 35.  Vital signs are within normal limits.  On physical examination, the patient has a harsh systolic murmur.  The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy.

Patient description (patient's own words): I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average.

Does the patient match the trial criteria? Contradiction