Table 2.
Summary of Early-Terminated Publications
| First Author, Year (Reference No.) | CSP Study No. | Publication Title | Clinicaltrials.Gov National Clinical Trial No. | Condition or Disease | Intervention | Primary Outcome | Actual No. | Expected No. | Primary Reason for Early Termination | Secondary Reason For Early Termination | Sponsor |
| Lin, 2020 (6) | 553 | Chemotherapy after prostatectomy for high-risk prostate carcinoma: a phase III randomized study | NCT00132301 | Prostate cancer | Docetaxel plus prednisone vs. standard of care | Progression-free survival | 298 | 636 | Enrollment | CSP; Sanofi | |
| Kamalesh, 2013 (7) | 557 | Percutaneous coronary intervention versus coronary bypass surgery in United States veterans with diabetes | NCT00326196 | Coronary artery disease | PCI vs. CABG | Death or nonfatal MI | 198 | 790 | Enrollment | CSP | |
| Brilakis, 2018 (8) | 571 | Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomized trial | NCT01121224 | Saphenous vein graft atherosclerosis | BMS vs. DES | Death, MI, or revascularization | 597 | 762 | Enrollment | Funding | CSP |
| Rosenheck, 2011 (9) | 555 | Long-acting risperidone and oral antipsychotics in unstable schizophrenia | NCT00132314 | Schizophrenia/schizoaffective disorder | IM risperidone vs. oral antipsychotic | Time to hospitalization | 369 | 450 | Enrollment | Clinical practice | CSP |
| Lo, 2010 (10) | 558 | Robot-assisted therapy for long-term upper-limb impairment after stroke | NCT00372411 | Stroke | Robot-assisted therapy vs. intensive therapy vs. standard of care | Fugl-Meyer Assessment for Motor Recovery scale | 127 | 158 | Enrollment | Futility | CSP; Burke Medical Research Institute |
| Bauman, 2013 (11) | 535 | The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury a randomized trial | NCT00101361 | Pressure ulcer | Oxandrolone vs. placebo | Time to full healing | 212 | 400 | Futility | CSP | |
| McFall, 2010 (12) | 519 | Integrating tobacco cessation into mental health care for posttraumatic stress disorder: a randomized controlled trial | NCT00118534 | Mental health, PTSD, tobacco use disorder | Integrated care for smoking cessation vs. standard of care | Prolonged abstinence | 943 | 1,400 | Benefit | CSP | |
| O’Dell, 2013 (13) | 551 | Therapies for active rheumatoid arthritis after methotrexate failure | NCT00405275 | Rheumatoid arthritis | Etanercept vs. placebo | Change in disease activity score for 28 joints | 353 | 450 | Funding | CSP | |
| Fried, 2013 (14) | 565 | Combined angiotensin inhibition for the treatment of diabetic nephropathy | NCT00555217 | Kidney disease, type 2 diabetes | Losartan monotherapy vs. losartan plus lisinopril | Rate of glomerular filtration rate decline, development of end-stage renal disease, and death | 1,448 | 1,850 | Safety | CSP | |
| Fan, 2012 (15) | 560 | A comprehensive care management program to prevent chronic obstructive pulmonary disease hospitalizations: a randomized, controlled trial | NCT02036294 | COPD | COPD self-management education vs. standard of care | Time to first hospitalization for COPD | 426 | 960 | Safety | CSP | |
| Holodniy, 2011 (16) | 512 | Results of antiretroviral treatment interruption and intensification in advanced multi-drug resistant HIV infection from the OPTIMA Trial | NCT00050089 | HIV infection | No ARDFP vs. ARDFP; standard ART vs. mega-ART (5 or more anti-HIV drugs) | New or recurrent AIDS or death | 368 | 390 | Clinical practice | CSP; MRC; CIHR |
Abbreviations: AIDS, acquired immunodeficiency syndrome; ARDFP, antiretroviral drug–free period; ART, antiretroviral therapy; BMS, bare-metal stent; CABG, coronary artery bypass grafting; CIHR, Canadian Institutes of Health Research; COPD, chronic obstructive pulmonary disease; CSP, Cooperative Studies Program Study; DES, drug-eluting stent; HIV, human immunodeficiency virus; IM, intramuscular; MI, myocardial infarction; MRC, Medical Research Council; PCI, percutaneous coronary infusion; PTSD, post-traumatic stress disorder; VA, Veterans Affairs.