Trial Outcomes & Findings for Aspirin for Prevention of Venous Thromboembolism Among Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy (NCT NCT04352439)

NCT ID: NCT04352439

Last Updated: 2022-09-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 19 participants
• Primary outcome timeframe: Up to six months
• Results posted on: 2022-09-26

Participant Flow

Participant milestones

Measure	Aspirin Patients with a Khorana risk score of 1 receive 81 mg aspirin daily while receiving neoadjuvant chemotherapy for ovarian cancer. Aspirin: 81 mg aspirin daily
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aspirin for Prevention of Venous Thromboembolism Among Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy

Baseline characteristics by cohort

Measure	Aspirin n=19 Participants Patients with a Khorana risk score of 1 receive 81 mg aspirin daily while receiving neoadjuvant chemotherapy for ovarian cancer. Aspirin: 81 mg aspirin daily
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants
Age, Categorical >=65 years	15 Participants n=93 Participants
Age, Continuous	70 years STANDARD_DEVIATION 7.7 • n=93 Participants
Sex: Female, Male Female	19 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants
Race (NIH/OMB) White	15 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	19 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to six months

Outcome measures

Measure	Aspirin n=19 Participants Patients with a Khorana risk score of 1 receive 81 mg aspirin daily while receiving neoadjuvant chemotherapy for ovarian cancer. Aspirin: 81 mg aspirin daily
Number of Participants Experiencing a Venous Thromboembolism	4 Participants

PRIMARY outcome

Timeframe: Up to six months

Adverse events will only include those that are determined to be related to the study drug.

Outcome measures

Measure	Aspirin n=19 Participants Patients with a Khorana risk score of 1 receive 81 mg aspirin daily while receiving neoadjuvant chemotherapy for ovarian cancer. Aspirin: 81 mg aspirin daily
Number of Participants With at Least One Adverse Event	0 Participants

PRIMARY outcome

Timeframe: Up to six months

Population: Data not collected.

Patient adherence to aspirin as defined by percent of pills used.

Outcome measures

Outcome data not reported

Adverse Events

Aspirin

Serious events: 6 serious events

Other events: 0 other events

Deaths: 8 deaths

Serious adverse events

Measure	Aspirin n=19 participants at risk Patients with a Khorana risk score of 1 receive 81 mg aspirin daily while receiving neoadjuvant chemotherapy for ovarian cancer. Aspirin: 81 mg aspirin daily
Vascular disorders DVT	21.1% 4/19 • Number of events 4 • Up to 6 months with an average of 2.5 months. Patient records were reviewed regularly for adverse events.
Blood and lymphatic system disorders sepsis	5.3% 1/19 • Number of events 1 • Up to 6 months with an average of 2.5 months. Patient records were reviewed regularly for adverse events.
Blood and lymphatic system disorders thrombocytopenia	5.3% 1/19 • Number of events 1 • Up to 6 months with an average of 2.5 months. Patient records were reviewed regularly for adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brittany Davidson

Duke University

Phone: +1 919 684 0188

Email: brittany.davidson@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place