Table 3. Characteristics of cerebrovascular trials of class I/II treatment interventions.
| 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 | 44 | 74,249 | 7 | 15.9 | NA |
| Publication, y | |||||
| • 1983–1988 | 2 | 1,109 | 0 | 0.0 | Ref |
| •1989–1994 | 0 | 0 | 0 | N/a | 1 |
| • 1995–2000 | 7 | 2,300 | 0 | 0.0 | 1 |
| •2001–2006 | 11 | 17,435 | 1 | 9.1 | 1 |
| •2007–2012 | 14 | 38,385 | 3 | 21.4 | 1 |
| •2013–2016 | 10 | 15,020 | 3 | 30.0 | 1 |
| Trial protocol registered | |||||
| • Yes | 24 | 52,520 | 6 | 25.0 | Ref |
| • No | 20 | 21,729 | 1 | 5.0 | 0.106 |
| Trial randomization size | |||||
| • 100–499 | 18 | 4,839 | 0 | 0.0 | Ref |
| • 500–999 | 10 | 6,388 | 2 | 20.0 | 0.119 |
| •1000–4999 | 13 | 31,070 | 4 | 30.8 | 0.028 |
| • >5000 | 3 | 31,952 | 1 | 33.3 | 0.143 |
| Sites | |||||
| • Single-center | 4 | 667 | 0 | 0.0 | Ref |
| • Multi-center | 40 | 73,582 | 7 | 17.5 | 1 |
| Location | |||||
| • United States/Canada | 11 | 33,751 | 4 | 36.4 | Ref |
| • Europe | 22 | 22,555 | 0 | 0.0 | 0.008 |
| • Asia/Australia | 11 | 17,943 | 3 | 27.3 | 1 |
| Funding source | |||||
| • Academic grant/government | 25 | 30,891 | 3 | 12.0 | Ref |
| • Industry | 8 | 28,911 | 2 | 25.0 | 0.574 |
| • Both | 10 | 14,139 | 2 | 20.0 | 0.61 |
| • Not specified | 1 | 308 | 0 | 0.0 | 1 |
| Journal | |||||
| • Lancet Neurology | 6 | 3,040 | 1 | 16.7 | Ref |
| • Lancet | 7 | 13,569 | 0 | 0.0 | 0.462 |
| • Stroke | 11 | 9,509 | 0 | 0.0 | 0.353 |
| • New England Journal of Medicine | 15 | 41,168 | 6 | 40.0 | 0.613 |
| • Others (Journal of American Medical Association, BMC Med, Journal of Internal Medicine) | 5 | 6,963 | 0 | 0.0 | 1 |
| Diagnostic category | |||||
| • Ischemic stroke | 24 | 46,709 | 4 | 16.7 | Ref |
| • ICH | 6 | 9,026 | 2 | 33.3 | 0.571 |
| • Ischemic stroke or ICH | 2 | 942 | 0 | 0.0 | 1 |
| • Ischemic stroke or TIA | 5 | 7,342 | 1 | 20.0 | 1 |
| • SAH | 1 | 109 | 0 | 0.0 | 1 |
| • Stroke | 5 | 4,016 | 0 | 0.0 | 1 |
| • Stroke or TIA | 1 | 6,105 | 0 | 0.0 | 1 |
| • TIA | 0 | 0 | 0 | N/a | 1 |
| Therapeutic class—Broad | |||||
| • Medication | 25 | 52,155 | 5 | 20.0 | Ref |
| • Procedure | 4 | 1,207 | 1 | 25.0 | 1 |
| • Both medication and procedure | 0 | 0 | 0 | N/a | 1 |
| • Other* | 16 | 23,907 | 2 | 12.5 | 0.685 |
| Therapeutic class—Specific‡ | |||||
| • Antiplatelet | 11 | 30,360 | 3 | 27.3 | Ref |
| • Anticoagulant | 8 | 25,627 | 2 | 25.0 | 1 |
| • Fibrinolytics | 8 | 9,196 | 1 | 12.5 | 0.603 |
| • Care pathway | 16 | 23,907 | 2 | 12.5 | 0.371 |
| • Endovascular treatment | 3 | 1,081 | 1 | 33.3 | 1 |
| • Other† | 6 | 12,888 | 1 | 16.7 | 1 |
*Other: care pathway
†Other: ACEI, ARB, BB, CCB, statin, US waves
‡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.