What side effects are associated with this type of intervention?

The most common treatments for Pulmonary Embolism (PE) include anticoagulants and thrombolytics. Anticoagulants such as heparin, warfarin, and direct oral anticoagulants (DOACs) like rivaroxaban and apixaban can cause side effects including bleeding, bruising, and, in rare cases, heparin-induced thrombocytopenia. Thrombolytics like alteplase, which are used to dissolve clots, can lead to significant bleeding complications, including intracranial hemorrhage. Other side effects may include allergic reactions, hypotension, and reperfusion arrhythmias.

What prior FDA approvals exist?

The FDA has approved several treatments for pulmonary embolism, primarily focusing on anticoagulants and thrombolytics. Anticoagulants such as heparin, low molecular weight heparin (e.g., enoxaparin), and direct oral anticoagulants (e.g., rivaroxaban, apixaban) are commonly used to prevent clot progression. Thrombolytics like alteplase are used in more severe cases to dissolve clots. These treatments work by inhibiting clot formation or breaking down existing clots, which may be relevant to the mechanism of action being studied in the TS23 trial.

What other types of research exist?

Promising novel alternatives to TS23 for pulmonary embolism patients in 2024 include PF-06741086, a monoclonal antibody targeting tissue factor pathway inhibitor; PB2452, a ticagrelor reversal agent; recombinant variants of tissue-type plasminogen activator (t-PA); and thrombus targeting aspirin particles (T-APP) for imaging and therapy.

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Antiplasmin Inactivator

TS23 for Pulmonary Embolism (NAIL-IT Trial)

Phase 2

Recruiting

Led By Guy L Reed, MD

Research Sponsored by Translational Sciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is hemodynamically stable with a systolic blood pressure (SBP) >90 mm Hg

Subject has evidence of RV dysfunction as indicated by a right ventricular-to-left ventricular (RV/LV) diameter ratio > 0.9 on CTPA scan (measuring the minor axis of the right and left ventricle in the transverse plane), prior to the initiation of study drug administration

Must not have

Subjects with acute or persistent hepatitis or diagnosed active liver disease or with elevation of liver enzymes: Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 3 x upper limit of normal (ULN)

Subjects who are considered at very high risk of bleeding: Known coagulation disorder with history of pathologic bleeding tendencies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours after treatment

Summary

This trial is testing a new drug called TS23 to see if it can safely help dissolve blood clots in the lungs of patients with significant but not immediately life-threatening clots. The drug works by breaking down these clots to improve blood flow and breathing.

Who is the study for?

This trial is for adults over 18 with a recent pulmonary embolism (PE) confirmed by scan, showing specific heart dysfunction but stable blood pressure. It's not for those at high bleeding risk, with certain liver conditions, low blood counts, or severe kidney issues. Pregnant or breastfeeding women and those not using effective birth control are excluded.

What is being tested?

The NAIL-IT Trial is testing TS23 against a placebo in phase II to see if it can safely dissolve blood clots in the lungs. Participants will be randomly assigned to either the drug or placebo group.

What are the potential side effects?

While side effects of TS23 aren't detailed here, common risks may include bleeding due to clot breakdown and potential allergic reactions to new medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood pressure is stable and above 90 mm Hg.

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My heart scan shows right ventricle enlargement compared to the left.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver is healthy and my liver enzyme levels are not three times above the normal limit.

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I have a bleeding disorder that makes me bleed easily.

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I need to take two different blood-thinning medications at the same time.

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I cannot take standard blood thinners or certain medications due to allergies or reactions.

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I have had a brain bleed, brain vessel malformation, or aneurysm.

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My kidney function is low, with a creatinine clearance less than 30 mL/min or serum creatinine ≥ 2.5 mg/dL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

RV/LV

Safety- Bleeding

Secondary study objectives

Thrombus dissolution

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Low dose TS23Experimental Treatment1 Intervention

TS23 low dose + SOC anticoagulation

Group II: Intermediate dose TS23Experimental Treatment1 Intervention

TS23 medium dose + SOC anticoagulation

Group III: Higher dose TS23Experimental Treatment1 Intervention

TS23 highest dose + SOC anticoagulation

Group IV: PlaceboPlacebo Group1 Intervention

Placebo + standard of care (SOC) anticoagulation

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Pulmonary Embolism (PE) include anticoagulants and thrombolytics. Anticoagulants, such as heparin, low molecular weight heparin (LMWH), and direct oral anticoagulants (DOACs), inhibit various factors in the coagulation cascade to prevent further clot formation. Thrombolytics, like tissue plasminogen activator (tPA), dissolve existing clots by converting plasminogen to plasmin, which breaks down fibrin. These mechanisms are crucial for PE patients as anticoagulants prevent clot extension and new clot formation, while thrombolytics rapidly restore blood flow in acute, life-threatening situations.