Aspirin for Prophylaxis of TTP

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Sep 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of aspirin to help prevent strokes in patients with a rare blood condition called Thrombotic Thrombocytopenic Purpura (TTP). TTP can lead to serious health issues, including strokes and kidney problems, particularly in patients who have low levels of a specific enzyme called ADAMTS13. Researchers want to see if taking aspirin regularly can improve the health and survival of patients with a type of TTP known as congenital (cTTP) and acquired (iTTP) when they are in a stable condition, meaning they are not currently experiencing severe symptoms.

To be eligible for this study, participants must have a confirmed diagnosis of TTP and low ADAMTS13 levels, but they should not be showing severe symptoms at the time of screening. Key criteria include having a stable platelet count and no history of stroke. Participants will need to follow the study guidelines and attend regular check-ups, but the risks of taking aspirin are generally low, and it is an inexpensive medication. This trial aims to provide more information on whether aspirin can help improve outcomes for these patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Those who voluntarily signed the informed consent form and were able to comply with the study protocol.
• • 2. Subjects diagnosed with severe ADAMTS13 deficiency, defined as ADAMTS13 activity \<10%, documented in the patient's medical history or at screening. Note: In patients receiving fresh frozen plasma (FFP) or other prophylactic treatments containing ADAMTS13 products, plasma ADAMTS13 activity levels at screening may exceed 10%. hTTP will be documented by ADAMTS13 activity \<10% and biallelic pathogenic ADAMTS13 mutations. Patients with hTTP may be asymptomatic. iTTP will be diagnosed by ADAMTS13 activity \<10% and the presence of an ADAMTS13 activity inhibitor (or comparable test for anti-ADAMTS13 antibodies). The diagnosis of hTTP may be supported by the recovery of ADAMTS13 activity to \>10% during clinical remission.
• • 3. Subjects do not exhibit any severe symptoms of TTP at the time of screening. At screening, patients with mild but stable laboratory abnormalities (LDH not higher than three times the upper limit of normal; platelet count not less than 100,000/microliter) are eligible for enrollment.
• • 4. No stroke was detected on cranial MRI and there was no previous history of stroke.
• • 5. The subject is willing and able to comply with the requirements of this protocol.
• Exclusion Criteria:
• • 1. Subject has a history of significant neurological events, such as a major stroke, indicating that a relapse may have serious consequences, as judged by the investigator
• • 2. Subject has increased risk for bleeding (e.g., platelet count \<30,000/µL, severe coagulopathy, gastrointestinal disease)
• • 3. Subject has a history of drug and/or alcohol abuse within six months before enrollment.
• • 4. Subject has a life expectancy of fewer than three months.
• • 5. The investigator considers the subject unable or unwilling to cooperate with the study procedures.
• • 6. The subject is a family member or employee of the investigator.
• • 7. The patient is pregnant or breast-feeding.