A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Microvascular Obstruction

Treatments: Drug: Temanogrel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04848220

APD791-202

C5071002 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether intravenous temanogrel is a safe and effective treatment for microvascular obstruction (MVO) in adult participants undergoing percutaneous coronary intervention (PCI).

Full description

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to be conducted in 2 stages (Stage A and Stage B). Stage A is an ascending single-dose placebo-controlled study planned to consist of 2 cohorts. Stage B is a parallel-treatment group study planned to consist of a placebo group and 2 active treatment groups of temanogrel doses selected based on safety and tolerability data in Stage A.

Enrollment: 29 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable angina participants suitable for elective PCI, or participants suitable for PCI for diagnosis of non-ST-elevation myocardial infarction or unstable angina (NSTEMI/UA) who are consistently hemodynamically stable until the time of PCI and have a thrombolysis in myocardial infarction (TIMI) Flow Grade 2 or 3 on the diagnostic angiography
• Target lesions for PCI must appear suitable for stenting as confirmed on the diagnostic angiography and must satisfy the study criteria regarding lesion size and vessel diameter/type.
• Females must not be of childbearing potential
• Males with pregnant or non-pregnant female partners of childbearing potential must agree to using a condom during treatment and for 90 days following treatment

Exclusion criteria

• Planned or anticipated use of rotational atherectomy/ablation or shockwave therapies during the PCI procedure
• Any history of stroke, seizure, intracranial bleeding, or intracranial aneurysm
• Transient ischemic attack within the 6 months prior to Screening
• History of major trauma, major surgery, and/or clinically significant head injury or hemorrhage within the last 6 months of Screening
• Any ST-elevation myocardial infarction (STEMI) within 10 days of Screening or STEMI within the target vessel territory within the last 4 months of Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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29 participants in 3 patient groups, including a placebo group

Stage A (Dose Cohort 1) and Stage B (Dose Group 1)

Experimental group

Treatment:

Drug: Temanogrel

Stage A (Dose Cohort 2) and Stage B (Dose Group 2)

Experimental group

Treatment:

Drug: Temanogrel

Stage A (Dose Cohort 1 and Dose Cohort 2) and Stage B (Dose Group 1 and Dose Group 2)

Placebo Comparator group

Treatment:

Drug: Placebo