Please select the eligibility criteria that correspond to the clinical trial below.
Title: Secondary Prevention of Small Subcortical Strokes (SPS3) Trial
Brief Summary: The goal of this study is to learn if combination antiplatelet therapy (aspirin and clopidogrel) is more effective than aspirin alone for the prevention of recurrent stroke and cognitive decline, and if intensive blood pressure control is associated with fewer recurrent strokes and cognitive decline.

On July 21, 2011 the DSMB recommended terminating the anti platelet arm of the study due to an imbalance of overall and major non-CNS hemorrhagic SAE's and total deaths in the investigational anti platelet combination of aspirin + clopidogrel and an interim statistical analysis that demonstrated futility in the investigational anti platelet arm. It was recommended that patients be continued on standard care of aspirin mono therapy until their study close-out visit. Also, recommended the continuation and completion of the plood pressure arm following the protocol.


Options:
A: INCLUSION:

Small subcortical ischemic stroke or subcortical TIA.

Inclusion criteria are based on TOAST criteria supplemented by required MRI data. All of the following criteria must be met:

* One of the lacunar stroke clinical syndromes (adapted from Fisher) lasting \> 24 hrs within the past 6 months
* Absence of signs or symptoms of cortical dysfunction such as aphasia, apraxia, agnosia, agraphia, homonymous visual field defect, etc.
* No ipsilateral cervical carotid stenosis (≥50%) by a reliable imaging modality done in an approved laboratory since the qualifying small subcortical stroke (S3), if hemispheric.
* No major-risk cardioembolic sources requiring anticoagulation or other specific therapy. Minor-risk cardioembolic sources will be permitted if anticoagulation is not prescribed by the patient's primary care physician.
* Subcortical TIA with corresponding lesion on DWI.
* MRI evidence of S3: a. Presence of an S3 (1.5 and 2 cm in diameter corresponding to the qualifying event on DWI; when TIA, ADC image must confirm lesion or T2/FLAIR (hyperintense lesions) (required for all brainstem events) OR multiple S3s on FLAIR/TI(\<1.5 cm in diameter) (hypointense lesions) b. Absence of cortical stroke and large subcortical stroke (recent or remote).

EXCLUSION:

To be eligible for entry into the study, the patient must not meet any of the criteria listed below:

* Disabling stroke (Modified Rankin Scale less than or equal to 4)
* Previous intracranial hemorrhage (excluding traumatic) or hemorrhagic stroke
* Age under 30 years
* High risk of bleeding (e.g. recurrent GI or GU bleeding, active peptic ulcer disease, etc)
* Anticipated requirement for long-term use of anticoagulants (e.g. recurrent DVT) or other antiplatelets
* Prior cortical stroke (diagnosed either clinically or by neuroimaging), or prior cortical or retinal TIA
* Prior ipsilateral carotid endarterectomy
* Impaired renal function: GFR \<40
* Intolerance or contraindications to aspirin or clopidogrel (including thrombocytopenia, prolonged INR)
* A score \< 24 (adjusted for age and education) on the Folstein Mini Mental Status Examination
* Medical contraindication to MRI
* Pregnancy or women of child-bearing potential who are not following an effective method of contraception
* Geographic or social factors making study participation impractical
* Unable or unwilling to provide informed consent
* Unlikely to be compliant with therapy/unwilling to return for frequent clinic visits
* Patients concurrently participating in another study with an investigational drug or device
* Other likely specific cause of stroke (e.g. dissection, vasculitis, prothrombotic diathesis, drug abuse)
B: Inclusion Criteria:

* A stroke specialist-determined ischemic stroke or TIA within the past year (including ocular strokes/TIA such as amaurosis fugax).
* Presence of systemic hypertension (average systolic blood pressure over two visits - i.e., SPC visit and study screening visit- exceeding 140 mmHg) OR fasting LDL cholesterol exceeding 2.0 mmol/L OR total: HDL cholesterol ratio exceeding 4.0 at SPC visit.

Exclusion Criteria:

* Neurological event considered to be due to intracranial hemorrhage (e.g., ICH, SAH), or trauma induced, or related to structural heart disease such as ASD/VSD or endocarditis.
* Foreshortened life-expectancy (e.g., active malignancy), hypertensive crisis (clinic systolic BP \> 200 mm Hg), or severe comorbidities.
* Institutionalized in a long-term care facility.
* Cognitive impairment (defined as a score of \> 5 on the Short Portable Mental Status questionnaire).
* Already on maximal therapy for risk factors (on 3 antihypertensive drugs at maximal dose if hypertension is inclusion criterion or on maximal dose statin if hyperlipidemia is inclusion criterion).
C: Inclusion Criteria:

* Veterans 18 years or older hospitalized with stroke or Transient Ischemic Attack at Indianapolis Veterans Administration Medical Center and Houston Veteran Administration Medical Center;
* willing to participate;
* access to telephone;
* speaks and understands English;
* no severe cognitive impairments;
* life expectancy of at least 6 mos;
* willingness to follow-up in Veterans Administration outpatient care.

Exclusion Criteria:

* Severe aphasia or cognitive impairment;
* active alcohol or substance abuse;
* cannot or unwilling to participate;
* does not speak or understand English;
* life expectancy less than 6 mos;
* no access to telephone;
* no Veterans Administration outpatient follow-up.
D: Inclusion Criteria:

1. Above the age of 18 years; male or female
2. Index stroke symptoms began no greater than one month before enrollment
3. Uncontrolled hypertension (SBP ≥140 mmHg) based upon last inpatient or outpatient encounter clinic within previous 12 months
4. Legally competent
5. Owns or has close home-sharing family member with a cell phone

Exclusion Criteria:

1. Failure to meet any inclusion criteria
2. Severe cognitive impairment/dementia (Modified Mini-Mental Score \[MMSE\] ≤24)\*
3. Severe global disability (modified Rankin Scale Score \[mRS\] ≥ 3)\*
4. Renal dialysis; awaiting renal transplant or transplant recipient
5. Cancer diagnosis or treatment in past 2 years
6. Planned pregnancy
7. Vulnerable populations such as pregnant or nursing women, prisoners, and institutionalized individuals.

   * MMSE ≤24 and global disability (mRS ≥ 3) excludes patients who have severe cognitive impairments and medical limitations that would interfere with adequate participation in the PINGS project.

Answer: A