Heart drug trial halted after only 6 patients
NCT ID NCT04723186
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tested a new drug called MT1002 in 6 people having a heart procedure (PCI) after a heart attack. The goal was to see if it could safely control blood clotting. However, the study was stopped early, so we don't have enough information to know if the drug works or is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MT1002 (an injectable drug to prevent blood clots during heart procedures)
- What this could lead to
- If it had worked, MT1002 might have offered a new option to control blood clotting during heart procedures, potentially reducing complications.
- What could go wrong
- This was a very small, early-phase trial that was terminated early, so we have little data on safety or effectiveness. The drug may not work or could cause serious bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
6 people
The number who actually took part.
- Started
-
Dec 2020
- Finished
-
Aug 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males and females ≥ 18 to 85 years of age. 2. Diagnosed with NSTEMI. 3. Patients who will undergo PCI during the index hospitalization for an NSTEMI. 4. Ability to understand and willing to give written informed consent. 5. Women of childbearing potential must have a negative pregnancy test or be post-menopausal for at least 1 year before enrollment or be permanently sterilized since ≥6 weeks. Females of childbearing potential and males with partners of childbearing potential must be using effective contraception. Exclusion Criteria: 1. .Cardiogenic shock or prolonged cardiopulmonary resuscitation (CPR). 2. Active bleeding, bleeding diathesis, coagulopathy. 3. Any history of intracranial bleeding or structural abnormalities. 4. Prior transient ischemic attack, prior stroke within 6 months. 5. Index MI is STEMI or new left bundle branch block. 6. The following planned procedures within 30 days after enrollment: staged PCI, CABG, valve surgery, or additional invasive procedures. 7. Pre-existing atrial fibrillation or prolonged QTcF (470ms in men, 480ms in women). 8. Anticipated requirement for oral anticoagulants before Day 30. 9. CRUSADE bleeding risk score \>40. 10. Suspected aortic dissection. 11. History of gastrointestinal or genitourinary bleeding within the previous 3 months. 12. Refusal to receive blood transfusion if needed during the study. 13. Major surgery in the last month. 14. History of heparin-induced thrombocytopenia and bleeding diathesis. 15. Severe uncontrolled hypertension. 16. Prior (within 30 days prior to enrollment) or planned administration of thrombolytics, glycoprotein IIb/IIIa inhibitors, bivalirudin, or fondaparinux for the index MI. 17. Known relevant hematological deviations: hemoglobin (male) \< 11 g/dL, hemoglobin (female) \< 10 g/dL, hematocrit \< 35%, platelet count \< 100,000 cells/µL. 18. Use of Coumadin derivatives and/or Factor Xa inhibitor drugs within the last 7 days. 19. Chronic therapy with non-steroidal anti-inflammatory drugs (NSAIDs; except aspirin) , cyclooxygenase (COX)-2 inhibitors within 1 month before screening. 20. Known malignancies or other comorbid conditions with life expectancy \< 1 year. 21. Known severe liver disease (i.e., aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] \> 3 × ULN). 22. Known positive serology for hepatitis B \& C, HIV screen. 23. Known chronic kidney disease with estimated glomerular filtration rate (eGFR) \<30 mL/min and/or dialysis. 24. Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, bivalirudin, unfractionated heparin, P2Y12 antagonists, or contrast.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
IU Health - BMH
Muncie, Indiana, 47303, United States
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