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NCT01036802 · ClinicalTrials.gov registry record · Phase 2

Anticoagulation For Pulmonary Hypertension in Sickle Cell Disease

A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.

Terminated
Registry status
Phase 2
Development phase
3
Enrollment target

NCT01036802: Clinical Trial Phase 2 study, sponsored by University of North Carolina, Chapel Hill.

NCT01036802 is a Phase 2 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01036802, a Phase 2 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.

TERMINATED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study Summary

Sickle cell disease (SCD) is often referred to as a hypercoagulable state. However, the contribution of coagulation activation to the pathogenesis of SCD remains uncertain. Pulmonary hypertension (PHT) is a common complication associated with significant morbidity and mortality. Autopsy studies of SCD patients with PHT show evidence of in situ thrombosis involving pulmonary vessels, similar to findings in non-sickle cell patients with PHT. Anticoagulation has been reported to be of benefit in non-sickle cell patients with PHT. With the evidence of increased coagulation activation in SCD, PHT represents a clinical endpoint that may be used to evaluate the contribution of coagulation activation to the pathophysiology of SCD. The investigators hypothesize that increased thrombin generation, as well as platelet activation are central to the pathophysiology of SCD and contribute to the occurrence of several SCD-related complications, including PHT. As a consequence, treatment modalities that down-regulate thrombin generation would be expected to delay the progression of PHT and result in improved survival in patients with SCD.

Primary Outcome

We determined the effect of anticoagulation with warfarin on estimated pulmonary artery systolic pressure obtained by Doppler echocardiography. The presented data are average values for the study subjects in the treatment group. When data was missing, the previous value was carried forward.

Interventions

  • DRUG Placebo
  • DRUG Warfarin

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2009-12
Est. Completion 2012-09
Phase Phase 2

Why NCT01036802 stopped before completion

NCT01036802 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01036802 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01036802 about?

NCT01036802 is a clinical study titled "Anticoagulation For Pulmonary Hypertension in Sickle Cell Disease". Sickle cell disease (SCD) is often referred to as a hypercoagulable state. However, the contribution of coagulation activation to the pathogenesis of SCD remains uncertain. Pulmonary hypertension (PHT) is a common complication associated with significant morbidity and mortality. Autopsy studies of S...

What is the current status of trial NCT01036802?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2009-12. Estimated completion is 2012-09.

What interventions are being tested in trial NCT01036802?

The interventions under investigation include: Placebo (DRUG), Warfarin (DRUG).

Who is sponsoring clinical trial NCT01036802?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01036802's enrollment target sits among peer trials

3 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01036802, the US trial registry maintained by the National Library of Medicine. NCT01036802 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.