Table 1. Characteristics of cerebrovascular trials.
| Trials | Number of Patients | Trials with Explicit Exclusion of Renal Disease Patients Based on Index Report, Methods Report of Registered Protocol, n | Percent | p value | |
|---|---|---|---|---|---|
| Overall | 135 | 194,977 | 48 | 35.6 | NA |
| Publication, year | |||||
| • 1983–1988 | 4 | 2,617 | 0 | 0.0 | Ref |
| • 1989–1994 | 3 | 493 | 1 | 33.3 | 0.429 |
| • 1995–2000 | 15 | 8,905 | 2 | 13.3 | 1 |
| • 2001–2006 | 34 | 52,765 | 10 | 29.4 | 0.556 |
| • 2007–2012 | 42 | 76,220 | 17 | 40.5 | 0.281 |
| • 2013–2016 | 37 | 53,977 | 18 | 48.6 | 0.118 |
| Class I/II recommendation | |||||
| • Yes | 44 | 74,249 | 7 | 15.9 | Ref |
| • No | 91 | 120,748 | 41 | 45.1 | 0.001 |
| Trial protocol registered | |||||
| • Yes | 77 | 133,474 | 35 | 45.5 | Ref |
| • No | 58 | 61,503 | 13 | 22.4 | 0.007 |
| Trial randomization size | |||||
| • 100–499 | 63 | 16,915 | 18 | 28.6 | Ref |
| • 500–999 | 27 | 18,120 | 8 | 29.6 | 1 |
| • 1000–4999 | 38 | 82,902 | 19 | 50.0 | 0.035 |
| • >5000 | 7 | 77,040 | 3 | 42.9 | 0.421 |
| Sites | |||||
| • Single-center | 12 | 2,769 | 3 | 25.0 | Ref |
| • Multi-center | 123 | 192,208 | 45 | 36.6 | 0.538 |
| Location | |||||
| • Europe | 70 | 91,431 | 20 | 28.6 | Ref |
| • United States/Canada | 43 | 73,395 | 20 | 46.5 | 0.069 |
| • Asia/Australia/South America | 22 | 30,151 | 8 | 36.4 | 0.596 |
| Funding source | |||||
| • Academic grant/government | 52 | 65,560 | 11 | 21.2 | Ref |
| • Industry | 50 | 93,418 | 21 | 42.0 | 0.033 |
| • Both | 23 | 26,314 | 11 | 47.8 | 0.028 |
| • Not specified | 10 | 9,685 | 5 | 50.0 | 0.108 |
| Journal | |||||
| • Lancet | 25 | 69,326 | 6 | 24.0 | Ref |
| • Stroke | 48 | 27,379 | 15 | 31.3 | 0.594 |
| • NEJM | 32 | 70,608 | 15 | 46.9 | 0.1 |
| • Lancet Neurology | 15 | 9,955 | 8 | 53.3 | 0.089 |
| • JAMA | 8 | 13,466 | 3 | 37.5 | 0.651 |
| • Others (Archives of Internal Medicine, BMC Medicine, Circulation, Journal of Internal Medicine, Neurology) | 7 | 4,243 | 1 | 14.3 | 0.006 |
| Diagnostic category | |||||
| • Ischemic stroke | 77 | 81,068 | 27 | 35.1 | Ref |
| • ICH | 11 | 11,279 | 3 | 27.3 | 0.743 |
| • Ischemic stroke or ICH | 6 | 6,874 | 2 | 33.3 | 1 |
| • Ischemic stroke or TIA | 18 | 64,585 | 7 | 38.9 | 0.789 |
| • SAH | 7 | 5,548 | 4 | 57.1 | 0.415 |
| • Stroke | 12 | 18,140 | 4 | 33.3 | 1 |
| • Stroke or TIA | 2 | 6,846 | 0 | 0.0 | 0.544 |
| • TIA | 2 | 637 | 1 | 50.0 | 1 |
| Therapeutic class—Broad‡ | |||||
| • Medication | 89 | 159,539 | 36 | 40.4 | Ref |
| • Procedure | 20 | 10,083 | 7 | 35.0 | 0.801 |
| • Both medication and procedure | 4 | 1,674 | 2 | 50.0 | 1 |
| • Other* | 23 | 26,701 | 3 | 13.0 | 0.015 |
| Therapeutic class—Specific‡ | |||||
| • Antiplatelet | 31 | 91,293 | 13 | 41.9 | Ref |
| • Anticoagulant | 15 | 30,565 | 6 | 40.0 | 1 |
| • Fibrinolytics | 14 | 10,211 | 2 | 14.3 | 0.094 |
| • Care pathway | 21 | 25,810 | 4 | 19.0 | 0.132 |
| • Endovascular treatment | 13 | 6,637 | 6 | 46.2 | 1 |
| • Other† | 57 | 63,729 | 24 | 42.1 | 1 |
*Other: educational material, care pathway, anesthesia plan.
†Other: ACEI, anesthesia plan, antibiotic, ARB, BB, benzothiazole derivative, CCB, defibrinogenating agent, educational material, endothelin receptor antagonist, EPO, factor replacement, free radical-trapping agent, GCSF, glycerol, hemicraniectomy, hemodilution, insertable cardiac monitoring, insulin, intercellular adhesion molecule-1 (ICAM-1) antibody, magnesium, nitroglycerin, NMDA receptor antagonist, platelet transfusion, peptide, PFO closure, remote ischemic preconditioning, sedative/hypnotic, serotonin agonist, statin, supplement, thiazolidinedione, transcranial laser treatment, US waves, uric acid, zinc chelator.
‡The sum of the number of trials based on the therapeutic class of the examined intervention is greater than the total number of trials, because several trials evaluated multiple interventions and thus were counted for each category. The sum of the percentages is greater than 100% for this reason.